Real World Testing of a Brain-Computer Interface

Sponsor

University of Pittsburgh (Other)

Overall Status

Recruiting

CT.gov ID

NCT04026581

Collaborator

National Institute on Disability, Independent Living, and Rehabilitation Research (U.S. Fed)

Enrollment

Locations

50.9

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this project is to test a new AAC-BCI device comparing gel and dry electrode headgear used for communication while providing clinical care. Innovative resources will be employed to support the standard of care without considering limitations based on service billing codes. Clinical services will include AAC assessment, AAC-BCI device and treatment to individuals with minimal movement due to amyotrophic lateral sclerosis (ALS), brain stem strokes, severe cerebral palsy, traumatic brain injury (TBI) and their family support person. This is a descriptive study designed to measure and monitor the communication performance of individuals using the AAC-BCI, any other AAC strategies, their user satisfaction and perceptions of communication effectiveness, and the satisfaction of the family support persons.

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis Brain Stem Stroke Cerebral Palsy Traumatic Brain Injury Speech Disorders	Behavioral: Speech generating device (SGD) evaluation including BCI access Behavioral: Training and treatment

Detailed Description

This clinical trial follows a descriptive study design collecting data to measure and monitor variables related to the standard of care in providing speech language pathology augmentative and alternative communication clinical (AAC) assessment and treatment. The study tracks participants through the AAC, speech generating device trial and AAC-BCI trial processes. In addition this study measures and monitors the communication performance of individuals using the AAC-BCI and any other AAC strategies for treatment in the home. Data on communication performance, user satisfaction, and perceptions of communication effectiveness are gathered over monthly visits along with the satisfaction and perceptions of communication effectiveness by the family support persons.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Real World Testing of a Brain-Computer Interface to Operate a Commercial Augmentative and Alternative Communication System

Actual Study Start Date :

Jun 5, 2019

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Assessment A comprehensive AAC assessment collecting clinical and personal data required to select a speech-generating device (SGD) is conducted along with a trial of three AAC technology solutions, followed by a trial for BCI access to an AAC system.	Behavioral: Speech generating device (SGD) evaluation including BCI access At the initial evaluation the participants will review the full range of AAC options and speech generating devices (SGDs) and complete a speech and language evaluation. The second evaluation date will involve a trial of SGDs matched to the participant's assessment results. The third visit is the trial of an AAC system with BCI access. Should the dry electrode headgear for BCI access prove ineffective, then the gel electrode cap will be offered to the participant for trial. At the end of the third visit, the evaluation results will be discussed with participant and family, and they will be asked to select the preferred SGD.
Training and Treatment AAC training and treatment services will be provided and communication performance outcomes monitored over the course of studying clinical treatment services. At monthly home visits the SLP gathers clinical and personal data on communication performance outcomes and user satisfaction of their AAC system and any alternative access methods.	Behavioral: Training and treatment Participants receive training on the selected SGD followed by monthly treatment sessions from the SLP who monitors performance. In some cases the participants' SGD will be an AAC system with BCI access. In this case training will also include an identified system support person. Use of the SGD is monitored on a monthly basis through home visits and/or tele-practice sessions, when requested. Technical support for the SGD is provided on an as needed basis or when requested by the participant or support person.

Arm

Intervention/Treatment

Assessment

A comprehensive AAC assessment collecting clinical and personal data required to select a speech-generating device (SGD) is conducted along with a trial of three AAC technology solutions, followed by a trial for BCI access to an AAC system.

Behavioral: Speech generating device (SGD) evaluation including BCI access

At the initial evaluation the participants will review the full range of AAC options and speech generating devices (SGDs) and complete a speech and language evaluation. The second evaluation date will involve a trial of SGDs matched to the participant's assessment results. The third visit is the trial of an AAC system with BCI access. Should the dry electrode headgear for BCI access prove ineffective, then the gel electrode cap will be offered to the participant for trial. At the end of the third visit, the evaluation results will be discussed with participant and family, and they will be asked to select the preferred SGD.

Training and Treatment

AAC training and treatment services will be provided and communication performance outcomes monitored over the course of studying clinical treatment services. At monthly home visits the SLP gathers clinical and personal data on communication performance outcomes and user satisfaction of their AAC system and any alternative access methods.

Behavioral: Training and treatment

Participants receive training on the selected SGD followed by monthly treatment sessions from the SLP who monitors performance. In some cases the participants' SGD will be an AAC system with BCI access. In this case training will also include an identified system support person. Use of the SGD is monitored on a monthly basis through home visits and/or tele-practice sessions, when requested. Technical support for the SGD is provided on an as needed basis or when requested by the participant or support person.

Outcome Measures

Primary Outcome Measures

Change in daily communication performance [Baseline vs. 1 month]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [1 month vs. 2 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [2 months vs. 3 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [3 months vs. 4 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [4 months vs. 5 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [5 months vs. 6 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [6 months vs. 7 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [7 months vs. 8 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [8 months vs. 9 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [9 months vs. 10 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [10 months vs. 11 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [11 months vs. 12 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [12 months vs. 13 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [13 months vs. 14 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [14 months vs. 15 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [15 months vs. 16 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [16 months vs. 17 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [17 months vs. 18 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [18 months vs. 19 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [19 months vs. 20 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [20 months vs. 21 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [21 months vs. 22 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [22 months vs. 23 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.
Change in daily communication performance [23 months vs. 24 months]
Monitoring daily use of a speech generating device (SGD) for communication. Average communication rate based on total number of words used during the day.

Secondary Outcome Measures

User satisfaction of speech generating device (SGD) for daily communication [Baseline vs. 1 month]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [1 month vs. 2 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [2 months vs. 3 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [3 months vs. 4 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [4 months vs. 5 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [5 months vs. 6 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [6 months vs. 7 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [7 months vs. 8 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [8 months vs. 9 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [9 months vs. 10 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [10 months vs. 11 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [11 months vs. 12 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [12 months vs. 13 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [13 months vs. 14 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [14 months vs. 15 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) or daily communication [15 months vs. 16 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [16 months vs. 17 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [17 months vs. 18 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [18 months vs. 19 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [19 months vs. 20 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [20 months vs. 21 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [21 months vs. 22 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [22 months vs. 23 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.
User satisfaction of speech generating device (SGD) for daily communication [23 months vs. 24 months]
Rating scale of user satisfaction with a range of 0-21 with a lower score representing a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

natural speech does not meet daily communication needs requiring using a speech generating device
Has a diagnosis resulting in minimal movement interfering with direct selection to a keyboard or AAC display
age 14 and above
able to read a standard computer screen
able to follow instructions
English as their native language

Exclusion Criteria:

history of photosensitive epilepsy
open sores on the scalp
history of uncorrectable hearing loss
unavailable to participate during the times scheduled for the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AAC Institute Clinic (ICAN Talk Clinic)	Carnegie	Pennsylvania	United States	15102
2	University of Pittsburgh, AAC Performance and Testing Laboratory	Pittsburgh	Pennsylvania	United States	15260