TDS-1: Evaluation of a Tongue Operated Assistive Technology for Individuals With Severe Paralysis

• Sponsor: Georgia Institute of Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT01124292
• Collaborator: Shepherd Center, Atlanta GA (Other), Northwestern University (Other), Shirley Ryan AbilityLab (Other), University of Arizona (Other)
• Enrollment: 61
• Locations: 4
• Arms: 3
• Duration (Months): 22
• Patients Per Site: 15.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This study was intended to evaluate a new assistive neuro-technology, known as the Tongue Drive System (TDS), by its potential end-users, i.e. individuals with severe disabilities, who are the best experts for indicating the benefits and possible shortcomings of any new ANT. Our goal is to assess the acceptability and usability of the TDS for various tasks that are important in daily lives of these individuals, such as computer access, wheeled mobility, and environmental control.

Condition or Disease	Intervention/Treatment	Phase
Quadriplegia; Spinal Cord Injury; ALS	Procedure: Tongue Piercing; Device: Usability assessment	Phase 1

Detailed Description

A new assistive neuro-technology (ANT), called the Tongue Drive System (TDS), enables individuals with severe disability access their environment with nothing but their tongue motion. The human tongue is inherently capable of sophisticated control and manipulation tasks with many degrees of freedom. It can move rapidly and accurately within the mouth such that the tip can touch every single tooth. The direct connection between the brain and the tongue generally allows it to escape damage even in severe spinal cord injuries (SCI). Unlike the brain, the tongue is accessible, and its location inside the mouth affords a degree of privacy.

TDS consists of a magnetic tracer, the size of a lentil, attached to the tongue by gluing, implantation, or piercing. The tracer generates a magnetic field inside and around the mouth that is detected by an array of magnetic sensors mounted on a wireless headset. Tongue-movement-induced changes in the magnetic field are sent wirelessly to an ultra-mobile computer or smartphone, carried by the user, which processes and translates every tongue motion to a particular user-defined function.

Once an individual with disability is "enabled" to access a computing device, he/she can nearly do everything that an able-bodied individual can do with that device. This includes communicating, education, training, entertainment, and controlling other devices such as powered wheelchairs (PWC), assistive robotic manipulators, and other home/office appliances on a local area network (LAN). Even the individual's own natural or prosthetic limbs can be manipulated to move by functional electrical stimulation (FES).

This study was intended to evaluate the TDS by the ultimate intended users, individuals with severe disabilities, who are the best experts for indicating the benefits and possible shortcomings of any new ANT. Our goal is to assess the acceptability and usability of the TDS for various tasks that are important in daily life such as computer access, wheeled mobility, and environmental control.

Three groups of subjects were recruited:

Group-A: Able-bodied subjects who already have tongue piercing

Group-B: Able-bodied subjects who wanted to receive tongue piercing as part of this trial

Group-C: Subjects with high-level disability, who wanted to receive tongue piercing as part of this trial

Each group of subjects participated in a battery of tasks that quantitatively measures their performance in accessing computers and driving wheelchairs using the TDS.

We also devised acceptable procedures for receiving a magnetic tongue piercing (required in order to use the TDS), and assess its potential safety issues.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Development and Translational Assessment of a Tongue-Based Assistive Neuro-Technology for Individuals With Severe Neurological Disorders
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Able-bodied subject with piercing Able-bodied subjects who already have tongue piercing.	Device: Usability assessment; Computer access: Subjects wear the TDS and get trained. Then they sit 1.5 m from a 22" LCD monitor. Then they use TDS to conduct several tasks using their tongues, such as clicking on target objects and navigating through on-screen maze, while the computer registers their tongue commands and measures their performance. Wheelchair control: Subjects wear the TDS and use it to drive an electrically powered wheelchair through an obstacle course using their tongues. The operator measured the time it takes for the subjects to drive through the course as well as the number of collisions.
Experimental: Able-bodied subject without piercing Able-bodied subjects who willing to receive a tongue piercing for this study.	Procedure: Tongue Piercing; Subjects brush their teeth, and then swish and spit with chlorhexidine mouthwash for 30-60s. Subjects would be placed in a semirecumbent position in a procedure chair. After marking the piercing site using a sterilized surgical marking pen the protruded tongue would be pierced. Anesthesia may be used during the piercing at the discretion of the operator and the subject. A sterilized titanium or surgical grade stainless steel piercing tongue stud would be placed in an appropriate position on the tongue to minimize complications from the piercing but also facilitate good functionality of the TDS.; Device: Usability assessment; Computer access: Subjects wear the TDS and get trained. Then they sit 1.5 m from a 22" LCD monitor. Then they use TDS to conduct several tasks using their tongues, such as clicking on target objects and navigating through on-screen maze, while the computer registers their tongue commands and measures their performance. Wheelchair control: Subjects wear the TDS and use it to drive an electrically powered wheelchair through an obstacle course using their tongues. The operator measured the time it takes for the subjects to drive through the course as well as the number of collisions.
Experimental: Subjects with spinal cord injury Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.	Procedure: Tongue Piercing; Subjects brush their teeth, and then swish and spit with chlorhexidine mouthwash for 30-60s. Subjects would be placed in a semirecumbent position in a procedure chair. After marking the piercing site using a sterilized surgical marking pen the protruded tongue would be pierced. Anesthesia may be used during the piercing at the discretion of the operator and the subject. A sterilized titanium or surgical grade stainless steel piercing tongue stud would be placed in an appropriate position on the tongue to minimize complications from the piercing but also facilitate good functionality of the TDS.; Device: Usability assessment; Computer access: Subjects wear the TDS and get trained. Then they sit 1.5 m from a 22" LCD monitor. Then they use TDS to conduct several tasks using their tongues, such as clicking on target objects and navigating through on-screen maze, while the computer registers their tongue commands and measures their performance. Wheelchair control: Subjects wear the TDS and use it to drive an electrically powered wheelchair through an obstacle course using their tongues. The operator measured the time it takes for the subjects to drive through the course as well as the number of collisions.

Outcome Measures

Primary Outcome Measures

1. Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Throughput) [24 months]

   Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

2. Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Error Rate) [24 months]

   Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

3. Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Throughput) [24 months]

   Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

4. Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Error Rate) [24 months]

   Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

5. Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Throughput) [24 months]

   Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP). Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

6. Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Error Rate) [24 months]

   Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP). Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

7. Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Movement Time) [24 months]

   Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The movement time is the cursor movement time from the initial movement to the final movement for each target. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP). Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

8. Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Throughput) [24 months]

   Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

9. Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Error Rate) [24 months]

   Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

10. Information Transfer Rate (ITR) [24 months]

    Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B &-C)1.0s,0.7s,0.5s, SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

11. Information Transfer Rate (Percentage of Correctly Completed Commands) [24 months]

    Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B &-C)1.0s,0.7s,0.5s,SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

12. On-screen Maze Using TDS, Keypad, and SnP (Completion Time) [24 months]

    Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

13. On-screen Maze Using TDS, Keypad, and SnP (Sum of Deviation / 1000) [24 months]

    Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

14. Driving a Wheelchair Using TDS vs SnP (Completion Time) [24 months]

    An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles. Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions. Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed. Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right. Group-A&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks.

15. Driving a Wheelchair Using TDS vs SnP (Number of Navigation Errors) [24 months]

    An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles. Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions. Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed. Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right. Group-A&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks.

16. Phone Dialing Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time) [24 months]

    Randomly selected ten-digit target phone number was visually prompted on the top of the smartphone screen, and the subject entered the same number in the following line as quickly and as accurately as possible. If the wrong number was registered, then the subjects were allowed to delete the one by issuing the deleting command.At the end of the number entering, the subject needs to move the cursor at the green colored "CALL" button, in the middle of the bottom line, and it should be selected to complete the trial. The completion time and error rate were considered to evaluate the performance. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

17. Weight Shifting Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time) [24 months]

    The TDS commands were designated to change the wheelchair mode from driving to tilting and to control the wheelchair angle. The completion time was from the initial mode change to the end of the weight shifting. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

18. Short Questionnaire at the End of Each Session Group-A&-B:5 Consecutive TDS Trials (Intervals Ranging From Two to Ten Days) Group-C:Computer and PWC Within a Week, Over 6 Weeks. [24 months]

    Q1.How much thought was necessary to decide where to put your tongue to issue a specific command?1:A lot,5:A Little Q2.Was the speed of the movement of the cursor on the computer screen:1:Too slow,3:Just right,5:Too fast Q3.How difficult was pointing accurately at specific targets on the computer screen?1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1: Very difficult,5:Very easy (TDS:Q4-1.Unlatched,Q4-2.Latched,Q4-3.Semi-pro,SnP:Q4-4.Latched) Q5.Was the speed of the wheelchair:1:Too slow,5:Too fast Q6.Was the movement of the wheelchair:1:Very jerky,5:Very smooth Q7.Was TDS effective in dialing phone numbers:1:Completely ineffective,5:Very effective Q8.Was TDS effective in doing the weight shift:1:Completely ineffective,5:Very effective

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Inclusion group-A:

• Age 18-65

• Able-bodied with a tongue piercing Must have had the tongue piercing for at least 3 months and still be using it

• Piercing is located in the midline of the tongue between the tip and the frenulum, almost in the center of the mouth

• Can understand and speak English

• Have some experience in using computers

Inclusion group-B:

• Age 18-65

• No overt sign of disability or neurological disease

• Do not have a tongue piercing, but are willing to receive one in the midline between the tip and lingual frenulum, almost in the center of the mouth

• Can understand and speak English

• Have some experience in using computers

Inclusion group-C:

• Age 18-65

• Have mobility limitations requiring a power wheel chair and also have inadequate upper limb strength to manage a hand or arm control i.e. have severe motor disabilities and need alternative control

• Either using or suitable for an alternative control

• Able to follow simple commands

• Sitting tolerance of at least 4 hours (each experiment session will be no more than 4 hours and the researcher follows the standard pressure relief schedule)

• Have some experience in using computers

• Be able to move the tongue

• Be able to speak or respond to questions by themselves or through an augmentative and alternative communication (AAC) device

• Be able to give consent

• Be able to have a caregiver, who can respond immediately in the event of an emergency, available during the period of the study.

• Can understand and speak English

• Have or are willing to receive a tongue piercing in the midline between the tip and the lingual frenulum, almost in the center of the mouth

Exclusion Criteria:

Exclusion Group-A:

• Original tongue piercing and the insertion site is too wide.

• Ongoing difficulties with current tongue jewelry

• Tongue piercing not located in the correct position on the tongue

• No experience with computers or illiterate

• Severe hearing or visual deficiency or impairing neurological disease

• Have any ongoing systemic condition deemed to be relevant by the local investigator-clinician

• Is pregnant

• Cognitive impairment so that unable to follow simple commands

• Wounds or ulcers on the head or in the mouth or on the tongue

• Using sensitive electronic implantable medical device such as a deep brain stimulator or a pacemaker in the upper body

• Intra-oral space occupying lesion or orthodontic appliance

• Unable to come to GT or RIC on a regular basis during the study-period

• Miss more than two appointments without prior notification

• Unable to comply with any of the procedures in the protocol

Exclusion Group-B:

• Tongue too short or the tongue web too far extended, making tongue piercing difficult

• Have a torus mandibularis or palatini or other space-occupying intra-oral lesion or orthodontic appliance

• No experience with computers or illiterate

• Severe hearing or visual deficiency or impairing neurological disease

• Cardiovascular and respiratory diseases, artificial heart valve, congenital heart disease

• On an immunosuppressive medication or otherwise immunocompromised

• Diabetic or have any other ongoing systemic condition deemed to be relevant by the local investigator-clinician

• Ongoing neoplastic disease other than localized basal cell or squamous cell carcinoma of the skin

• Have known asthma, physical urticaria or angioedema

• Have any current infectious condition

• Cognitive impairment to the extent that cannot follow simple commands

• Is pregnant

• Wounds or ulcers on the head or in the mouth or on the tongue

• Using sensitive electronic implantable medical device such as a deep brain stimulator or a pacemaker in the upper body

• Space occupying orthodontic appliances

• Unable to come SCA or NU for a tongue piercing, 72 hour visit and to GTB or RIC on a regular basis during the study-period

• Miss more than two appointments without prior notification

• Unable to comply with any of the procedures in the protocol

Exclusion Group-C:

• Unable to move the tongue

• Have a large object or tube in the mouth blocking tongue motion

• Tongue or tongue frenulum short or the tongue frenulum extended far forward, making tongue piercing difficult

• Have a torus mandibularis or palatini or other space-occupying intra-oral lesion or orthodontic appliance

• Medically or mentally unstable

• Known sensitivity or allergy to an adhesive

• Using a halo brace or facial pads that would block the use of a headset or headgear

• Cognitive impairment to the extent that the subject cannot follow simple commands

• Severe hearing or visual deficiency

• Cardiovascular and respiratory diseases, artificial heart valve, congenital heart disease

• On any form of anticoagulation including but not limited to warfarin, heparin, low-molecular-weight heparin, factor Xa inhibitors, aspirin, aspirin-containing products, or nonsteroidal anti-inflammatory medications that the subject's supervising attending physician states cannot be stopped during the pre-piercing period which may include not only the appropriate medication-specific washout period before the piercing but also up to 5 days after the procedure.

• On an immunosuppressive or otherwise immunocompromised

• Have a decubitus ulcer stage III or higher or a decubitus ulcer of any stage that is worsening.

• Diabetic or have any other ongoing systemic condition, as deemed to be relevant by the local investigator-clinician

• Ongoing neoplastic disease other than localized basal cell or squamous cell carcinoma of the skin

• Have known asthma, physical urticaria or angioedema

• Have any current infectious condition

• Is pregnant

• No experience with computers or illiterate

• Using a sensitive electronic implantable medical device such as a deep brain stimulator or a pacemaker in the upper body

• Unable to sit for 4 hours with pressure relief

• Wounds or ulcers on the head or in the mouth or on the tongue

• No continuous access to a caregiver

• Unable to come to the SCA or NMH for a three day stay for tongue piercing and to SCA or RIC on a regular basis during the study-period

• Miss more than three appointments without prior notification

• Unable to comply with any of the procedures in the protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgia Institute of Technology	Atlanta	Georgia	United States	30308
2	Shepherd Center	Atlanta	Georgia	United States	30309
3	Northwestern University	Chicago	Illinois	United States	60611
4	Rehabilitation Institute of Chicago	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Georgia Institute of Technology
• Shepherd Center, Atlanta GA
• Northwestern University
• Shirley Ryan AbilityLab
• University of Arizona

Investigators

• Principal Investigator: Maysam Ghovanloo, Ph.D., Georgia Institute of Technology

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• CNN report on the first clinical trial of the Tongue Drive System at the Shepherd Center in 2009
• Tongue Drive System description on the Georgia Tech research NEWS website, including a video clip showing the details of the first clinical trial at the Shepherd Center.
• Intraoral Tongue Drive System description on the Georgia Tech research NEWS website

Publications

• Huo X, Ghovanloo M. Evaluation of a wireless wearable tongue-computer interface by individuals with high-level spinal cord injuries. J Neural Eng. 2010 Apr;7(2):26008. doi: 10.1088/1741-2560/7/2/026008. Epub 2010 Mar 23.
• Huo X, Ghovanloo M. Using speech recognition to enhance the Tongue Drive System functionality in computer access. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:6393-6. doi: 10.1109/IEMBS.2011.6091578.
• Huo X, Ghovanloo M. Using unconstrained tongue motion as an alternative control mechanism for wheeled mobility. IEEE Trans Biomed Eng. 2009 Jun;56(6):1719-26. doi: 10.1109/TBME.2009.2018632. Epub 2009 Apr 7.
• Huo X, Wang J, Ghovanloo M. A magneto-inductive sensor based wireless tongue-computer interface. IEEE Trans Neural Syst Rehabil Eng. 2008 Oct;16(5):497-504. doi: 10.1109/TNSRE.2008.2003375.
• Huo X, Wang J, Ghovanloo M. Introduction and preliminary evaluation of the Tongue Drive System: wireless tongue-operated assistive technology for people with little or no upper-limb function. J Rehabil Res Dev. 2008;45(6):921-30.

• Responsible Party: Maysam Ghovanloo, Associate Processor, Georgia Institute of Technology
• ClinicalTrials.gov Identifier: NCT01124292
• Other Study ID Numbers: H09240; 1RC1EB010915-01
• First Posted: May 17, 2010
• Last Update Posted: Sep 18, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Maysam Ghovanloo, Associate Processor, Georgia Institute of Technology: Disability; Quadriplegia; Paralysis; Assistive technology; Quality of life; Computer access; Wheeled mobility
• Additional relevant MeSH terms: Spinal Cord Injuries; Quadriplegia

Study Results

Participant Flow

Recruitment Details	Able-bodied subjects (groups A and B) were recruited by using local IRB-approved flyers, emails, and electronically distributed documents. Subjects with spinal cord injuries were recruited from the in- and outpatient departments of the Shepherd Center and the Rehabilitation Institute of Chicago. (May. 2010 - March. 2012)

Arm/Group Title	Able-bodied Subject With Tongue Piercing	Able-bodied Subject Without Tongue Piercing	Subjects With Spinal Cord Injury
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Period Title: Overall Study
STARTED	16	24	21
COMPLETED	14	9	11
NOT COMPLETED	2	15	10

Baseline Characteristics

Arm/Group Title	Able-bodied Subject With Tongue Piercing	Able-bodied Subject Without Tongue Piercing:	Subjects With Spinal Cord Injury	Total
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.	Total of all reporting groups
Overall Participants	14	9	11	34
Age (Count of Participants)
<=18 years	1 7.1%	0 0%	0 0%	1 2.9%
Between 18 and 65 years	13 92.9%	9 100%	11 100%	33 97.1%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.12 (4.85)	22.56 (4.00)	38.30 (10.25)	27.61 (9.72)
Sex: Female, Male (Count of Participants)
Female	10 71.4%	5 55.6%	2 18.2%	17 50%
Male	4 28.6%	4 44.4%	9 81.8%	17 50%
Region of Enrollment (participants) [Number]
United States	14 100%	9 100%	11 100%	34 100%

Outcome Measures

1. Primary Outcome

Title	Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Throughput)
Description	Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11
first session using TDS	1.97 (0.44)	2.03 (0.44)	1.54 (0.56)
second session using TDS	2.04 (0.39)	2.22 (0.52)	1.75 (0.42)
third session using TDS	2.34 (0.32)	2.48 (0.51)	1.90 (0.51)
fourth session using TDS	2.37 (0.50)	2.54 (0.48)	2.14 (0.54)
fifth session using TDS	2.44 (0.52)	2.47 (0.54)	2.09 (0.41)
sixth session using TDS	NA (NA)	NA (NA)	2.22 (0.51)
first session using keypad	2.85 (0.41)	3.49 (0.68)	NA (NA)
second session using keypad	2.96 (0.45)	3.69 (0.48)	NA (NA)
third session using keypad	3.09 (0.52)	3.84 (0.54)	NA (NA)
fourth session using keypad	3.14 (0.48)	3.81 (0.59)	NA (NA)
fifth session using keypad	3.17 (0.52)	3.84 (0.57)	NA (NA)
first session using mouse	3.89 (0.97)	4.17 (0.68)	NA (NA)

2. Primary Outcome

Title	Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Error Rate)
Description	Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11
first session using TDS	29.14 (13.96)	23.85 (11.04)	37.84 (21.65)
second session using TDS	24.08 (17.30)	18.36 (10.11)	30.62 (18.02)
third session using TDS	24.64 (14.89)	13.70 (8.14)	28.77 (17.72)
fourth session using TDS	20.74 (14.36)	14.90 (9.34)	24.01 (14.16)
fifth session using TDS	17.96 (10.41)	16.34 (10.26)	18.45 (9.83)
sixth session using TDS	NA (NA)	NA (NA)	19.81 (12.63)
first session using keypad	9.49 (7.96)	10.63 (8.35)	NA (NA)
second session using keypad	6.94 (6.21)	8.44 (7.40)	NA (NA)
third session using keypad	6.70 (6.12)	5.97 (3.96)	NA (NA)
fourth session using keypad	5.03 (4.41)	8.12 (6.54)	NA (NA)
fifth session using keypad	4.99 (4.27)	6.24 (5.19)	NA (NA)
first session using mouse	9.24 (11.91)	2.14 (2.14)	NA (NA)

3. Primary Outcome

Title	Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Throughput)
Description	Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11
first session using TDS	2.14 (0.41)	2.22 (0.54)	1.44 (0.50)
second session using TDS	2.27 (0.37)	2.54 (0.51)	1.77 (0.54)
third session using TDS	2.31 (0.45)	2.74 (0.30)	1.79 (0.56)
fourth session using TDS	2.44 (0.36)	2.76 (0.45)	1.97 (0.33)
fifth session using TDS	2.61 (0.30)	2.69 (0.49)	2.01 (0.43)
sixth session using TDS	NA (NA)	NA (NA)	2.18 (0.60)
first session using keypad	2.84 (0.44)	3.46 (0.61)	NA (NA)
second session using keypad	2.90 (0.56)	3.88 (0.58)	NA (NA)
third session using keypad	3.03 (0.45)	3.85 (0.58)	NA (NA)
fourth session using keypad	3.10 (0.46)	3.96 (0.65)	NA (NA)
fifth session using keypad	3.11 (0.54)	3.93 (0.41)	NA (NA)
first session using mouse	4.28 (0.71)	4.32 (0.63)	NA (NA)

4. Primary Outcome

Title	Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Error Rate)
Description	Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11
first session using TDS	26.16 (15.39)	19.47 (9.95)	38.95 (19.61)
second session using TDS	21.83 (13.78)	15.88 (11.74)	30.37 (17.31)
third session using TDS	22.72 (12.43)	12.67 (7.52)	26.67 (15.57)
fourth session using TDS	20.30 (13.55)	10.97 (10.06)	23.77 (11.32)
fifth session using TDS	14.77 (11.79)	10.97 (7.71)	21.90 (11.35)
sixth session using TDS	NA (NA)	NA (NA)	19.99 (12.44)
first session using keypad	9.91 (8.92)	10.43 (7.80)	NA (NA)
second session using keypad	8.95 (7.91)	8.26 (5.72)	NA (NA)
third session using keypad	6.16 (6.02)	6.41 (5.55)	NA (NA)
fourth session using keypad	5.47 (5.42)	6.00 (4.82)	NA (NA)
fifth session using keypad	5.83 (5.44)	7.27 (6.01)	NA (NA)
first session using mouse	5.02 (7.37)	2.13 (2.28)	NA (NA)

5. Primary Outcome

Title	Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Throughput)
Description	Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP). Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11
first session using TDS	0.83 (0.32)	0.77 (0.48)	0.37 (0.21)
second session using TDS	1.23 (0.36)	0.96 (0.49)	0.52 (0.27)
third session using TDS	1.39 (0.26)	1.10 (0.40)	0.51 (0.31)
fourth session using TDS	1.41 (0.37)	1.29 (0.50)	0.73 (0.45)
fifth session using TDS	1.58 (0.25)	1.41 (0.53)	0.75 (0.45)
sixth session using TDS	NA (NA)	NA (NA)	0.81 (0.40)
first session using keypad	1.44 (0.46)	2.13 (0.57)	NA (NA)
second session using keypad	1.74 (0.47)	2.60 (0.44)	NA (NA)
third session using keypad	1.82 (0.29)	2.83 (0.36)	NA (NA)
fourth session using keypad	1.93 (0.32)	3.02 (0.30)	NA (NA)
fifth session using keypad	2.03 (0.27)	3.05 (0.53)	NA (NA)
first session using mouse	3.86 (0.54)	3.31 (0.50)	NA (NA)
first session using SnP	NA (NA)	NA (NA)	0.31 (0.20)
second session using SnP	NA (NA)	NA (NA)	0.42 (0.20)
third session using SnP	NA (NA)	NA (NA)	0.45 (0.19)
fourth session using SnP	NA (NA)	NA (NA)	0.51 (0.16)
fifth session using SnP	NA (NA)	NA (NA)	0.52 (0.17)
sixth session using SnP	NA (NA)	NA (NA)	0.52 (0.19)

6. Primary Outcome

Title	Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Error Rate)
Description	Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP). Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11
first session using TDS	37.65 (15.14)	41.41 (20.38)	61.98 (26.32)
second session using TDS	27.33 (12.18)	32.61 (12.51)	55.05 (24.75)
third session using TDS	23.02 (10.47)	23.87 (10.39)	48.15 (25.29)
fourth session using TDS	19.71 (10.80)	25.17 (13.93)	41.44 (23.40)
fifth session using TDS	17.52 (9.15)	19.84 (8.80)	36.54 (22.34)
sixth session using TDS	NA (NA)	NA (NA)	39.00 (27.32)
first session using keypad	12.66 (7.67)	6.68 (6.38)	NA (NA)
second session using keypad	11.81 (8.95)	4.86 (6.04)	NA (NA)
third session using keypad	9.67 (7.61)	1.33 (1.51)	NA (NA)
fourth session using keypad	7.69 (5.36)	2.08 (2.57)	NA (NA)
fifth session using keypad	6.72 (4.67)	2.38 (2.40)	NA (NA)
first session using mouse	4.46 (5.63)	2.95 (3.00)	NA (NA)
first session using SnP	NA (NA)	NA (NA)	42.50 (25.34)
second session using SnP	NA (NA)	NA (NA)	31.71 (20.80)
third session using SnP	NA (NA)	NA (NA)	26.67 (19.96)
fourth session using SnP	NA (NA)	NA (NA)	20.69 (15.41)
fifth session using SnP	NA (NA)	NA (NA)	19.83 (18.00)
sixth session using SnP	NA (NA)	NA (NA)	16.52 (12.52)

7. Primary Outcome

Title	Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Movement Time)
Description	Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The movement time is the cursor movement time from the initial movement to the final movement for each target. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP). Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11
first session using TDS	1.70 (0.30)	1.29 (0.15)	4.00 (1.41)
second session using TDS	1.33 (0.17)	1.22 (0.13)	3.18 (1.44)
third session using TDS	1.30 (0.17)	1.21 (0.11)	3.12 (1.38)
fourth session using TDS	1.34 (0.24)	1.22 (0.15)	2.81 (1.21)
fifth session using TDS	1.26 (0.16)	1.18 (0.08)	2.75 (1.25)
sixth session using TDS	NA (NA)	NA (NA)	2.75 (1.24)
first session using keypad	1.29 (0.15)	1.29 (0.39)	NA (NA)
second session using keypad	1.22 (0.13)	0.97 (0.12)	NA (NA)
third session using keypad	1.21 (0.11)	0.95 (0.14)	NA (NA)
fourth session using keypad	1.22 (0.15)	0.88 (0.11)	NA (NA)
fifth session using keypad	1.18 (0.08)	0.87 (0.12)	NA (NA)
first session using mouse	0.66 (0.08)	0.78 (0.07)	NA (NA)
first session using SnP	NA (NA)	NA (NA)	4.48 (1.08)
second session using SnP	NA (NA)	NA (NA)	4.14 (0.90)
third session using SnP	NA (NA)	NA (NA)	3.81 (0.71)
fourth session using SnP	NA (NA)	NA (NA)	3.69 (0.76)
fifth session using SnP	NA (NA)	NA (NA)	3.64 (0.83)
sixth session using SnP	NA (NA)	NA (NA)	3.79 (0.89)

8. Primary Outcome

Title	Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Throughput)
Description	Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11
first session using TDS	0.40 (0.19)	0.80 (0.30)	0.39 (0.17)
second session using TDS	0.62 (0.21)	0.93 (0.31)	0.42 (0.21)
third session using TDS	0.77 (0.30)	1.05 (0.30)	0.45 (0.16)
fourth session using TDS	0.85 (0.32)	1.10 (0.26)	0.65 (0.21)
fifth session using TDS	0.98 (0.26)	1.16 (0.31)	0.64 (0.27)
sixth session using TDS	NA (NA)	NA (NA)	0.73 (0.31)
first session using keypad	0.88 (0.28)	1.44 (0.20)	NA (NA)
second session using keypad	1.03 (0.24)	1.69 (0.20)	NA (NA)
third session using keypad	1.11 (0.21)	1.85 (0.17)	NA (NA)
fourth session using keypad	1.19 (0.18)	1.86 (0.22)	NA (NA)
fifth session using keypad	1.16 (0.22)	1.87 (0.23)	NA (NA)
first session using mouse	4.32 (0.59)	4.06 (0.60)	NA (NA)

9. Primary Outcome

Title	Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Error Rate)
Description	Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11
first session using TDS	32.67 (19.60)	21.34 (14.17)	54.91 (22.34)
second session using TDS	21.56 (13.87)	14.27 (9.69)	51.52 (27.88)
third session using TDS	18.42 (14.28)	10.73 (8.48)	37.27 (19.88)
fourth session using TDS	18.00 (15.27)	8.08 (6.67)	27.88 (25.15)
fifth session using TDS	14.67 (13.99)	6.86 (5.52)	29.47 (20.13)
sixth session using TDS	NA (NA)	NA (NA)	29.10 (24.28)
first session using keypad	7.25 (7.36)	2.62 (3.38)	NA (NA)
second session using keypad	6.38 (8.73)	1.64 (2.36)	NA (NA)
third session using keypad	3.99 (6.26)	1.30 (2.46)	NA (NA)
fourth session using keypad	3.65 (4.77)	1.84 (2.37)	NA (NA)
fifth session using keypad	4.96 (6.36)	1.44 (2.06)	NA (NA)
first session using mouse	6.77 (7.13)	2.78 (3.21)	NA (NA)

10. Primary Outcome

Title	Information Transfer Rate (ITR)
Description	Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B &-C)1.0s,0.7s,0.5s, SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11
1st ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s)	74.33 (5.99)	128.40 (23.44)	66.68 (25.01)
2nd ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s)	75.53 (5.18)	146.34 (12.40)	99.15 (41.14)
3rd ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s)	74.74 (6.38)	146.99 (15.44)	93.62 (32.01)
4th ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s)	74.89 (7.04)	146.29 (14.18)	112.85 (42.17)
5th ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s)	75.47 (6.66)	146.45 (12.83)	133.28 (24.46)
6th ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s)	NA (NA)	NA (NA)	127.83 (28.02)
1st ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s)	96.13 (14.07)	184.28 (37.04)	106.73 (36.05)
2nd ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s)	98.29 (8.90)	208.64 (19.28)	126.94 (59.05)
3rd ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s)	98.14 (10.16)	208.15 (19.35)	120.41 (43.85)
4th ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s)	100.34 (7.82)	209.85 (18.94)	141.27 (53.89)
5th ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s)	101.40 (5.50)	208.45 (20.40)	164.80 (51.32)
6th ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s)	NA (NA)	NA (NA)	169.31 (51.77)
1st ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s)	131.77 (24.28)	258.08 (47.10)	114.78 (45.40)
2nd ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s)	140.31 (19.85)	279.59 (39.96)	141.03 (43.06)
3rd ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s)	138.62 (17.13)	277.63 (42.97)	110.20 (67.33)
4th ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s)	146.82 (16.34)	282.89 (33.87)	127.45 (55.50)
5th ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s)	146.37 (14.43)	283.06 (37.54)	198.45 (77.99)
6th ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s)	NA (NA)	NA (NA)	175.21 (81.23)
1st ses. using SnP (Grp C T=1.2s)	NA (NA)	NA (NA)	24.14 (23.30)
2nd ses. using SnP (Grp C T=1.2s)	NA (NA)	NA (NA)	28.81 (24.00)
3rd ses. using SnP (Grp C T=1.2s)	NA (NA)	NA (NA)	37.34 (21.91)
4th ses. using SnP (Grp C T=1.2s)	NA (NA)	NA (NA)	52.04 (24.45)
5th ses. using SnP (Grp C T=1.2s)	NA (NA)	NA (NA)	54.44 (16.57)
6th ses. using SnP (Grp C T=1.2s)	NA (NA)	NA (NA)	54.70 (23.15)
1st ses. using SnP (Grp C T=1.0s)	NA (NA)	NA (NA)	18.12 (21.88)
2nd ses. using SnP (Grp C T=1.0s)	NA (NA)	NA (NA)	39.87 (31.31)
3rd ses. using SnP (Grp C T=1.0s)	NA (NA)	NA (NA)	52.03 (29.57)
4th ses. using SnP (Grp C T=1.0s)	NA (NA)	NA (NA)	57.79 (22.72)
5th ses. using SnP (Grp C T=1.0s)	NA (NA)	NA (NA)	57.73 (24.68)
6th ses. using SnP (Grp C T=1.0s)	NA (NA)	NA (NA)	55.23 (25.69)
1st ses. using SnP (Grp C T=0.7s)	NA (NA)	NA (NA)	28.81 (35.64)
2nd ses. using SnP (Grp C T=0.7s)	NA (NA)	NA (NA)	40.72 (35.24)
3rd ses. using SnP (Grp C T=0.7s)	NA (NA)	NA (NA)	39.89 (37.63)
4th ses. using SnP (Grp C T=0.7s)	NA (NA)	NA (NA)	54.66 (44.31)
5th ses. using SnP (Grp C T=0.7s)	NA (NA)	NA (NA)	54.30 (30.86)
6th ses. using SnP (Grp C T=0.7s)	NA (NA)	NA (NA)	65.00 (50.28)

11. Primary Outcome

Title	Information Transfer Rate (Percentage of Correctly Completed Commands)
Description	Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B &-C)1.0s,0.7s,0.5s,SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11
1st ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s)	98.62 (2.61)	93.51 (1.24)	73.87 (11.72)
2nd ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s)	99.12 (2.30)	98.15 (0.51)	83.70 (15.37)
3rd ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s)	98.75 (3.03)	98.73 (0.45)	83.93 (9.60)
4th ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s)	98.75 (3.45)	98.08 (0.61)	90.95 (10.80)
5th ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s)	99.79 (1.58)	98.17 (0.54)	94.63 (6.60)
6th ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s)	NA (NA)	NA (NA)	93.00 (7.64)
1st ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s)	97.50 (5.46)	93.18 (1.25)	96.92 (8.85)
2nd ses. using TDS (Grp A:T=1.5, Grp B&C T=0.7s)	98.33 (2.99)	98.06 (0.57)	82.54 (14.00)
3rd ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s)	98.20 (3.65)	97.99 (0.57)	78.70 (11.02)
4th ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s)	98.97 (2.69)	98.24 (0.56)	85.00 (11.75)
5th ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s)	99.37 (1.73)	98.01 (0.63)	91.47 (7.93)
6th ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s)	NA (NA)	NA (NA)	89.71 (11.71)
1st ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s)	94.61 (6.69)	93.67 (1.25)	69.34 (12.83)
2nd ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s)	96.53 (4.94)	96.44 (0.99)	73.91 (8.11)
3rd ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s)	94.32 (3.99)	96.12 (1.05)	67.66 (16.01)
4th ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s)	98.07 (4.04)	96.96 (0.77)	72.99 (13.34)
5th ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s)	98.07 (3.28)	96.87 (0.89)	84.87 (11.87)
6th ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s)	NA (NA)	NA (NA)	78.81 (14.70)
1st ses. using SnP (Grp C T=1.2s)	NA (NA)	NA (NA)	56.48 (22.92)
2nd ses. using SnP (Grp C T=1.2s)	NA (NA)	NA (NA)	62.65 (19.53)
3rd ses. using SnP (Grp C T=1.2s)	NA (NA)	NA (NA)	73.51 (15.05)
4th ses. using SnP (Grp C T=1.2s)	NA (NA)	NA (NA)	79.72 (13.96)
5th ses. using SnP (Grp C T=1.2s)	NA (NA)	NA (NA)	82.41 (9.05)
6th ses. using SnP (Grp C T=1.2s)	NA (NA)	NA (NA)	82.72 (10.57)
1st ses. using SnP (Grp C T=1.0s)	NA (NA)	NA (NA)	56.48 (21.85)
2nd ses. using SnP (Grp C T=1.0s)	NA (NA)	NA (NA)	62.65 (25.88)
3rd ses. using SnP (Grp C T=1.0s)	NA (NA)	NA (NA)	75.89 (15.44)
4th ses. using SnP (Grp C T=1.0s)	NA (NA)	NA (NA)	80.00 (12.11)
5th ses. using SnP (Grp C T=1.0s)	NA (NA)	NA (NA)	78.40 (11.15)
6th ses. using SnP (Grp C T=1.0s)	NA (NA)	NA (NA)	73.81 (16.62)
1st ses. using SnP (Grp C T=0.7s)	NA (NA)	NA (NA)	43.21 (26.15)
2nd ses. using SnP (Grp C T=0.7s)	NA (NA)	NA (NA)	54.63 (26.49)
3rd ses. using SnP (Grp C T=0.7s)	NA (NA)	NA (NA)	52.78 (24.40)
4th ses. using SnP (Grp C T=0.7s)	NA (NA)	NA (NA)	63.06 (28.17)
5th ses. using SnP (Grp C T=0.7s)	NA (NA)	NA (NA)	62.96 (21.72)
6th ses. using SnP (Grp C T=0.7s)	NA (NA)	NA (NA)	62.78 (26.15)

12. Primary Outcome

Title	On-screen Maze Using TDS, Keypad, and SnP (Completion Time)
Description	Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11
first session using TDS	27.80 (18.77)	23.36 (9.87)	34.27 (13.25)
second session using TDS	16.61 (4.35)	17.13 (5.72)	28.71 (12.58)
third session using TDS	15.41 (3.45)	16.81 (12.28)	32.70 (21.24)
fourth session using TDS	15.04 (3.57)	13.03 (4.49)	25.93 (9.91)
fifth session using TDS	14.26 (2.77)	12.59 (3.41)	25.99 (15.27)
sixth session using TDS	NA (NA)	NA (NA)	19.47 (14.66)
first session using keypad	20.26 (4.21)	17.56 (6.24)	NA (NA)
second session using keypad	16.76 (3.30)	13.14 (2.34)	NA (NA)
third session using keypad	15.30 (2.54)	12.31 (2.08)	NA (NA)
fourth session using keypad	14.65 (1.67)	11.76 (2.12)	NA (NA)
fifth session using keypad	14.25 (1.42)	10.96 (1.99)	NA (NA)
first session using SnP	NA (NA)	NA (NA)	49.86 (28.22)
second session using SnP	NA (NA)	NA (NA)	37.48 (18.15)
third session using SnP	NA (NA)	NA (NA)	33.49 (12.42)
fourth session using SnP	NA (NA)	NA (NA)	30.56 (10.08)
fifth session using SnP	NA (NA)	NA (NA)	30.65 (9.28)
sixth session using SnP	NA (NA)	NA (NA)	30.89 (10.33)

13. Primary Outcome

Title	On-screen Maze Using TDS, Keypad, and SnP (Sum of Deviation / 1000)
Description	Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11
first session using TDS	30.05 (89.76)	23.59 (20.28)	64.86 (91.42)
second session using TDS	4.51 (4.08)	13.27 (20.28)	41.86 (41.83)
third session using TDS	4.17 (5.20)	13.91 (31.22)	59.19 (84.68)
fourth session using TDS	4.54 (5.18)	5.89 (13.05)	28.43 (24.97)
fifth session using TDS	1.80 (1.68)	4.27 (3.58)	29.05 (35.49)
sixth session using TDS	NA (NA)	NA (NA)	17.18 (29.84)
first session using keypad	1.88 (2.32)	4.03 (5.85)	NA (NA)
second session using keypad	1.10 (1.48)	1.46 (1.82)	NA (NA)
third session using keypad	0.60 (1.01)	1.08 (1.01)	NA (NA)
fourth session using keypad	0.56 (0.66)	1.55 (1.40)	NA (NA)
fifth session using keypad	0.39 (0.60)	1.16 (1.57)	NA (NA)
first session using SnP	NA (NA)	NA (NA)	47.05 (104.05)
second session using SnP	NA (NA)	NA (NA)	20.26 (18.68)
third session using SnP	NA (NA)	NA (NA)	14.04 (11.87)
fourth session using SnP	NA (NA)	NA (NA)	12.19 (11.27)
fifth session using SnP	NA (NA)	NA (NA)	15.32 (19.02)
sixth session using SnP	NA (NA)	NA (NA)	11.17 (9.06)

14. Primary Outcome

Title	Driving a Wheelchair Using TDS vs SnP (Completion Time)
Description	An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles. Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions. Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed. Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right. Group-A&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11
first session using TDS (unlatched)	198.17 (34.01)	240.85 (81.77)	253.45 (70.11)
second session using TDS (unlatched)	169.21 (25.08)	194.93 (29.48)	219.46 (56.02)
third session using TDS (unlatched)	173.46 (30.27)	179.39 (29.80)	186.04 (18.25)
fourth session using TDS (unlatched)	170.00 (38.80)	179.74 (22.78)	183.70 (23.27)
fifth session using TDS (unlatched)	160.08 (18.22)	154.59 (23.52)	181.24 (27.39)
sixth session using TDS (unlatched)	NA (NA)	NA (NA)	170.76 (19.76)
first session using TDS (latched)	230.29 (48.45)	260.86 (84.97)	295.54 (151.08)
second session using TDS (latched)	192.46 (27.50)	210.22 (34.42)	264.78 (107.65)
third session using TDS (latched)	196.08 (35.78)	200.96 (39.60)	228.78 (101.65)
fourth session using TDS (latched)	181.42 (26.28)	193.75 (37.92)	217.63 (84.98)
fifth session using TDS (latched)	179.13 (23.22)	174.33 (34.15)	189.52 (19.68)
sixth session using TDS (latched)	NA (NA)	NA (NA)	179.37 (23.16)
first session using SnP (latched)	NA (NA)	NA (NA)	234.97 (70.94)
second session using SnP (latched)	NA (NA)	NA (NA)	213.28 (68.29)
third session using SnP (latched)	NA (NA)	NA (NA)	196.24 (37.78)
fourth session using SnP (latched)	NA (NA)	NA (NA)	183.98 (36.22)
fifth session using SnP (latched)	NA (NA)	NA (NA)	191.43 (38.12)
sixth session using SnP (latched)	NA (NA)	NA (NA)	182.33 (21.34)
first session using TDS (semi-pro)	196.54 (16.46)	232.75 (66.47)	319.21 (112.70)
second session using TDS (semi-pro)	178.58 (14.42)	205.44 (32.64)	239.18 (62.38)
third session using TDS (semi-pro)	177.75 (11.87)	206.71 (30.35)	233.92 (60.00)
fourth session using TDS (semi-pro)	178.83 (14.70)	196.57 (28.86)	212.67 (44.90)
fifth session using TDS (semi-pro)	175.25 (17.07)	177.50 (37.44)	181.18 (27.27)
sixth session using TDS (semi-pro)	NA (NA)	NA (NA)	204.96 (35.23)

15. Primary Outcome

Title	Driving a Wheelchair Using TDS vs SnP (Number of Navigation Errors)
Description	An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles. Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions. Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed. Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right. Group-A&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11
first session using TDS (unlatched)	2.67 (1.87)	8.44 (5.78)	8.76 (5.04)
second session using TDS (unlatched)	1.17 (1.30)	6.59 (6.76)	7.48 (4.85)
third session using TDS (unlatched)	1.08 (0.79)	3.96 (4.07)	5.82 (5.04)
fourth session using TDS (unlatched)	1.04 (1.46)	2.58 (2.26)	5.06 (4.03)
fifth session using TDS (unlatched)	0.75 (0.66)	2.22 (2.14)	2.97 (3.56)
sixth session using TDS (unlatched)	NA (NA)	NA (NA)	2.76 (3.46)
first session using TDS (latched)	3.50 (2.06)	7.80 (6.41)	10.61 (7.61)
second session using TDS (latched)	1.83 (1.13)	6.00 (2.77)	7.16 (5.00)
third session using TDS (latched)	1.38 (1.17)	4.79 (2.72)	7.03 (7.26)
fourth session using TDS (latched)	0.71 (1.06)	3.71 (3.16)	6.78 (9.51)
fifth session using TDS (latched)	0.96 (1.44)	3.70 (3.60)	3.06 (3.17)
sixth session using TDS (latched)	NA (NA)	NA (NA)	2.06 (2.26)
first session using SnP (latched)	NA (NA)	NA (NA)	4.27 (3.06)
second session using SnP (latched)	NA (NA)	NA (NA)	3.30 (2.01)
third session using SnP (latched)	NA (NA)	NA (NA)	3.82 (2.92)
fourth session using SnP (latched)	NA (NA)	NA (NA)	2.39 (2.59)
fifth session using SnP (latched)	NA (NA)	NA (NA)	2.97 (2.30)
sixth session using SnP (latched)	NA (NA)	NA (NA)	2.61 (2.16)
first session using TDS (semi-pro)	2.08 (1.23)	2.52 (1.41)	7.81 (3.94)
second session using TDS (semi-pro)	1.00 (0.91)	2.92 (1.76)	5.79 (3.85)
third session using TDS (semi-pro)	0.96 (0.84)	2.00 (2.52)	5.15 (3.76)
fourth session using TDS (semi-pro)	1.00 (1.18)	1.89 (0.96)	3.64 (2.97)
fifth session using TDS (semi-pro)	0.88 (1.04)	1.71 (1.69)	2.97 (3.56)
sixth session using TDS (semi-pro)	NA (NA)	NA (NA)	3.12 (3.20)

16. Primary Outcome

Title	Phone Dialing Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)
Description	Randomly selected ten-digit target phone number was visually prompted on the top of the smartphone screen, and the subject entered the same number in the following line as quickly and as accurately as possible. If the wrong number was registered, then the subjects were allowed to delete the one by issuing the deleting command.At the end of the number entering, the subject needs to move the cursor at the green colored "CALL" button, in the middle of the bottom line, and it should be selected to complete the trial. The completion time and error rate were considered to evaluate the performance. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	11
first session using TDS	187.69 (66.09)
second session using TDS	109.11 (47.05)
third session using TDS	89.99 (21.08)
fourth session using TDS	88.37 (29.56)
fifth session using TDS	89.37 (27.05)
sixth session using TDS	81.87 (22.75)

17. Primary Outcome

Title	Weight Shifting Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)
Description	The TDS commands were designated to change the wheelchair mode from driving to tilting and to control the wheelchair angle. The completion time was from the initial mode change to the end of the weight shifting. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	11
first session using TDS	116.19 (42.69)
second session using TDS	74.82 (39.10)
third session using TDS	78.24 (29.93)
fourth session using TDS	75.52 (29.60)
fifth session using TDS	74.46 (32.67)
sixth session using TDS	71.35 (23.22)

18. Primary Outcome

Title	Short Questionnaire at the End of Each Session Group-A&-B:5 Consecutive TDS Trials (Intervals Ranging From Two to Ten Days) Group-C:Computer and PWC Within a Week, Over 6 Weeks.
Description	Q1.How much thought was necessary to decide where to put your tongue to issue a specific command?1:A lot,5:A Little Q2.Was the speed of the movement of the cursor on the computer screen:1:Too slow,3:Just right,5:Too fast Q3.How difficult was pointing accurately at specific targets on the computer screen?1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1: Very difficult,5:Very easy (TDS:Q4-1.Unlatched,Q4-2.Latched,Q4-3.Semi-pro,SnP:Q4-4.Latched) Q5.Was the speed of the wheelchair:1:Too slow,5:Too fast Q6.Was the movement of the wheelchair:1:Very jerky,5:Very smooth Q7.Was TDS effective in dialing phone numbers:1:Completely ineffective,5:Very effective Q8.Was TDS effective in doing the weight shift:1:Completely ineffective,5:Very effective
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied Subject Without Tongue Piercing (Group-B)	Subjects With Spinal Cord Injury (Group-C): Computer Session	Subjects With Spinal Cord Injury (Group-C): Wheelchair Session
Arm/Group Description	Able-bodied subjects who already have tongue piercing.	Able-bodied subjects who willing to receive a tongue piercing for this study.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Measure Participants	14	9	11	11
Q1. (session1) 1: A lot, 5: A little	2.57 (1.16)	2.78 (0.67)	2.91 (1.38)	3.10 (1.29)
Q1. (session2) 1: A lot, 5: A little	4.07 (0.83)	3.44 (1.13)	3.90 (1.10)	3.91 (0.70)
Q1. (session3) 1: A lot, 5: A little	4.25 (0.87)	3.56 (1.01)	3.82 (0.87)	4.00 (1.10)
Q1. (session4) 1: A lot, 5: A little	4.50 (0.80)	3.63 (1.06)	3.91 (1.30)	3.73 (1.35)
Q1. (session5) 1: A lot, 5: A little	4.17 (0.96)	3.33 (1.00)	4.27 (0.90)	4.09 (1.83)
Q1. (session6) 1: A lot, 5: A little	NA (NA)	NA (NA)	4.36 (0.81)	NA (NA)
Q2. (session1) 1: Too slow, 3: Just right, 5: Too	3.21 (0.43)	3.11 (0.78)	3.27 (0.47)	NA (NA)
Q2. (session2) 1: Too slow, 3: Just right, 5: Too	3.07 (0.47)	3.22 (1.09)	0.34 (0.52)	NA (NA)
Q2. (session3) 1: Too slow, 3: Just right, 5: Too	3.00 (0.43)	3.22 (1.30)	3.00 (0.89)	NA (NA)
Q2. (session4) 1: Too slow, 3: Just right, 5: Too	3.00 (0.43)	3.13 (0.64)	3.27 (0.79)	NA (NA)
Q2. (session5) 1: Too slow, 3: Just right, 5: Too	3.08 (0.49)	3.00 (0.71)	3.18 (0.75)	NA (NA)
Q2. (session6) 1: Too slow, 3: Just right, 5: Too	NA (NA)	NA (NA)	3.18 (0.75)	NA (NA)
Q3. (session1) 1: Very difficult, 5: Very easy	2.71 (0.73)	3.56 (0.88)	3.36 (1.12)	NA (NA)
Q3. (session2) 1: Very difficult, 5: Very easy	3.43 (0.94)	2.89 (0.60)	3.90 (0.57)	NA (NA)
Q3. (session3) 1: Very difficult, 5: Very easy	3.50 (0.80)	3.11 (0.78)	3.64 (0.81)	NA (NA)
Q3. (session4) 1: Very difficult, 5: Very easy	3.92 (0.67)	3.75 (0.71)	3.91 (0.70)	NA (NA)
Q3. (session5) 1: Very difficult, 5: Very easy	4.15 (0.69)	3.00 (0.71)	4.09 (0.83)	NA (NA)
Q3. (session6) 1: Very difficult, 5: Very easy	NA (NA)	NA (NA)	4.27 (0.79)	NA (NA)
Q4.(ses1)1:Very difficult,5:Very easy(GrpC:Q4-1)	3.43 (0.76)	3.22 (1.20)	NA (NA)	4.10 (0.88)
Q4.(ses2)1:Very difficult,5:Very easy(GrpC:Q4-1)	3.93 (0.62)	4.11 (0.78)	NA (NA)	4.00 (0.77)
Q4.(ses3)1:Very difficult,5:Very easy(GrpC:Q4-1)	3.75 (0.87)	3.44 (0.88)	NA (NA)	3.64 (1.12)
Q4.(ses4)1:Very difficult,5:Very easy(GrpC:Q4-1)	4.25 (0.97)	3.50 (1.69)	NA (NA)	3.73 (1.01)
Q4.(ses5)1:Very difficult,5:Very easy(GrpC:Q4-1)	4.07 (0.92)	3.67 (1.12)	NA (NA)	3.82 (0.75)
Q5. (session1) 1: Too slow, 5: Too Fast	2.71 (0.47)	2.67 (0.87)	NA (NA)	2.70 (0.67)
Q5. (session2) 1: Too slow, 5: Too Fast	2.29 (0.61)	2.44 (0.73)	NA (NA)	2.64 (0.92)
Q5. (session3) 1: Too slow, 5: Too Fast	2.58 (0.67)	2.22 (0.67)	NA (NA)	0.64 (0.81)
Q5. (session4) 1: Too slow, 5: Too Fast	2.50 (0.67)	2.25 (0.46)	NA (NA)	2.55 (0.82)
Q5. (session5) 1: Too slow, 5: Too Fast	2.36 (0.63)	1.78 (0.67)	NA (NA)	2.27 (1.01)
Q6. (session1) 1: Very jerky, 5: Very smooth	4.14 (0.77)	3.67 (1.12)	NA (NA)	4.00 (0.94)
Q6. (session2) 1: Very jerky, 5: Very smooth	4.14 (0.86)	3.33 (0.71)	NA (NA)	3.91 (1.14)
Q6. (session3) 1: Very jerky, 5: Very smooth	4.50 (0.80)	3.22 (0.97)	NA (NA)	3.91 (1.04)
Q6. (session4) 1: Very jerky, 5: Very smooth	4.08 (1.08)	3.63 (0.92)	NA (NA)	4.00 (1.10)
Q6. (session5) 1: Very jerky, 5: Very smooth	4.00 (1.11)	3.63 (0.92)	NA (NA)	3.82 (1.08)
Q4.(ses1)1:Very difficult,5:Very easy(GrpC:Q4-2)	NA (NA)	NA (NA)	NA (NA)	3.20 (0.79)
Q4.(ses2)1:Very difficult,5:Very easy(GrpC:Q4-2)	NA (NA)	NA (NA)	NA (NA)	3.45 (1.13)
Q4.(ses3)1:Very difficult,5:Very easy(GrpC:Q4-2)	NA (NA)	NA (NA)	NA (NA)	3.91 (0.70)
Q4.(ses4)1:Very difficult,5:Very easy(GrpC:Q4-2)	NA (NA)	NA (NA)	NA (NA)	3.64 (1.36)
Q4.(ses5)1:Very difficult,5:Very easy(GrpC:Q4-2)	NA (NA)	NA (NA)	NA (NA)	3.91 (0.83)
Q4.(ses1)1:Very difficult,5:Very easy(GrpC:Q4-3)	NA (NA)	NA (NA)	NA (NA)	3.40 (1.43)
Q4.(ses2)1:Very difficult,5:Very easy(GrpC:Q4-3)	NA (NA)	NA (NA)	NA (NA)	3.73 (1.27)
Q4.(ses3)1:Very difficult,5:Very easy(GrpC:Q4-3)	NA (NA)	NA (NA)	NA (NA)	4.00 (0.89)
Q4.(ses4)1:Very difficult,5:Very easy(GrpC:Q4-3)	NA (NA)	NA (NA)	NA (NA)	4.00 (1.00)
Q4.(ses5)1:Very difficult,5:Very easy(GrpC:Q4-3)	NA (NA)	NA (NA)	NA (NA)	3.64 (0.92)
Q4.(ses1)1:Very difficult,5:Very easy(GrpC:Q4-4)	NA (NA)	NA (NA)	NA (NA)	2.70 (0.67)
Q4.(ses2)1:Very difficult,5:Very easy(GrpC:Q4-4)	NA (NA)	NA (NA)	NA (NA)	2.64 (0.92)
Q4.(ses3)1:Very difficult,5:Very easy(GrpC:Q4-4)	NA (NA)	NA (NA)	NA (NA)	2.64 (0.81)
Q4.(ses4)1:Very difficult,5:Very easy(GrpC:Q4-4)	NA (NA)	NA (NA)	NA (NA)	2.55 (0.82)
Q4.(ses5)1:Very difficult,5:Very easy(GrpC:Q4-4)	NA (NA)	NA (NA)	NA (NA)	2.27 (1.01)
Q7.(ses1)1:Completely ineffective,5:Very effective	NA (NA)	NA (NA)	NA (NA)	3.22 (1.86)
Q7.(ses2)1:Completely ineffective,5:Very effective	NA (NA)	NA (NA)	NA (NA)	4.00 (1.41)
Q7.(ses3)1:Completely ineffective,5:Very effective	NA (NA)	NA (NA)	NA (NA)	4.10 (1.37)
Q7.(ses4)1:Completely ineffective,5:Very effective	NA (NA)	NA (NA)	NA (NA)	4.40 (1.07)
Q7.(ses5)1:Completely ineffective,5:Very effective	NA (NA)	NA (NA)	NA (NA)	4.80 (0.63)
Q8.(ses1)1:Completely ineffective,5:Very effective	NA (NA)	NA (NA)	NA (NA)	3.71 (1.70)
Q8.(ses2)1:Completely ineffective,5:Very effective	NA (NA)	NA (NA)	NA (NA)	4.60 (0.97)
Q8.(ses3)1:Completely ineffective,5:Very effective	NA (NA)	NA (NA)	NA (NA)	4.70 (0.67)
Q8.(ses4)1:Completely ineffective,5:Very effective	NA (NA)	NA (NA)	NA (NA)	4.70 (0.67)
Q8.(ses5)1:Completely ineffective,5:Very effective	NA (NA)	NA (NA)	NA (NA)	4.70 (0.67)

Adverse Events

Arm/Group Title	Able-bodied Subject With Tongue Piercing (Group-A)		Able-bodied Subject Without Tongue Piercing (Group-B)		Subjects With Spinal Cord Injury (Group-C)
Arm/Group Description	Able-bodied subjects who already have tongue piercing.		Able-bodied subjects who willing to receive a tongue piercing for this study.		Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
All Cause Mortality
	Able-bodied Subject With Tongue Piercing (Group-A)		Able-bodied Subject Without Tongue Piercing (Group-B)		Subjects With Spinal Cord Injury (Group-C)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Able-bodied Subject With Tongue Piercing (Group-A)		Able-bodied Subject Without Tongue Piercing (Group-B)		Subjects With Spinal Cord Injury (Group-C)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/24 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Able-bodied Subject With Tongue Piercing (Group-A)		Able-bodied Subject Without Tongue Piercing (Group-B)		Subjects With Spinal Cord Injury (Group-C)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/24 (0%)		0/21 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.