Hand Function for Tetraplegia
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of an implanted stimulator for providing hand function to individuals with cervical level spinal cord injury. The device stimulates the paralyzed muscles of the hand and forearm. The user of the device controls the stimulation by moving muscles that are not paralyzed, such as a wrist or neck muscle. The ability of the user to pick up and move objects, as well as perform various activities such as eating, drinking, and writing.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The overall object of this research is to provide restored functional abilities to individuals with cervical-level spinal cord injury through the use of an advanced wireless myoelectrically controlled battery-powered implanted neuroprosthetic system known as the "FIRSTHAND" System. This restored function can enable the individual to achieve greater independence in activities of daily living and an improved quality of life. Electrical stimulation of paralyzed muscles will be used to generate functional movements. The movements will be controlled using myoelectric signals generated from muscles under the subject's voluntary control. The specific hypotheses of this study are: 1) at least 75% of all subjects will be able to manipulate at least one more object in the Grasp-Release Test when using the advanced neuroprosthesis compared to without the neuroprosthesis. 2) At least 75% of all subjects will demonstrate an increased level of independence in at least one functional activity when using the advanced neuroprosthesis. 3) At least 75% of all subjects will demonstrate an average neuroprosthesis usage of at least three days/week.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Neuroprosthesis System Receives implanted device for hand function. |
Device: FIRSTHAND System
Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels.
|
Outcome Measures
Primary Outcome Measures
- Grasp Release Test - Test of Functional Ability to Pick up and Move Objects [6-9 weeks]
Grasp and Release Test (GRT) - The Grasp and Release Test (GRT) [Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers [Peckham, 2001]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (~1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
cervical level spinal cord injury;
-
complete paralysis of fingers and thumbs;
-
voluntary shoulder motion;
-
electrically excitable forearm and hand musculature
Exclusion Criteria:
-
extreme contractures of the joints;
-
skeletal immaturity;
-
extensive denervation in the forearm and hand;
-
poor surgical risk
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | United States | 44106 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Kevin L Kilgore, PhD, Louis Stokes VA Medical Center, Cleveland, OH
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- A6027-R
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Note that the data from the first three (of 10) participants was published in the Journal of Hand Surgery (2008; 33(4):539-50). |
| Arm/Group Title | Neuroprosthesis System |
|---|---|
| Arm/Group Description | Subjects who have undergone implantation of the neuroprosthesis system known as the FIRSTHAND/IST-12 System. |
| Period Title: Rehab - Neuroprosthesis (NP) "On" | |
| STARTED | 10 |
| Grasp Release Pre-Test "ON" | 10 |
| COMPLETED | 10 |
| NOT COMPLETED | 0 |
| Period Title: Rehab - Neuroprosthesis (NP) "On" | |
| STARTED | 10 |
| Grasp Release Pre-Test "OFF" | 10 |
| COMPLETED | 10 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Neuroprosthesis System |
|---|---|
| Arm/Group Description | Receives implanted device for hand function. FIRSTHAND System: Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels. Also known as the "IST-12" System. |
| Overall Participants | 10 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
10
100%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
2
20%
|
| Male |
8
80%
|
| Grasp-Release Test (Number of Completions) [Median (Full Range) ] | |
| Median (Full Range) [Number of Completions] |
2
|
Outcome Measures
| Title | Grasp Release Test - Test of Functional Ability to Pick up and Move Objects |
|---|---|
| Description | Grasp and Release Test (GRT) - The Grasp and Release Test (GRT) [Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers [Peckham, 2001]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (~1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds. |
| Time Frame | 6-9 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Neuroprosthesis System |
|---|---|
| Arm/Group Description | Subjects with the implanted FIRSTHAND/IST-12 System. |
| Measure Participants | 10 |
| Rehab - NP "OFF" |
2
|
| Rehab - NP "ON" |
5.5
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Neuroprosthesis System | |
| Arm/Group Description | Receives implanted device for hand function. FIRSTHAND System: Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels. | |
All Cause Mortality |
||
| Neuroprosthesis System | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Neuroprosthesis System | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Neuroprosthesis System | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/10 (20%) | |
| Infections and infestations | ||
| Device Infection | 2/10 (20%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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.
Results Point of Contact
| Name/Title | Dr. Kevin Kilgore |
|---|---|
| Organization | Louis Stokes Cleveland VAMC |
| Phone | 216-9573657 |
| klk4@case.edu |
- A6027-R