CompletedNot Applicable

Real World Testing of a Brain-Computer Interface

United States19 participantsStarted 2019-06-05

Plain-language 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.

Who can participate

Age range

14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in daily communication performance

Timeframe: Baseline vs. 1 month

Change in daily communication performance

Timeframe: 1 month vs. 2 months

Change in daily communication performance

Timeframe: 2 months vs. 3 months

Change in daily communication performance

Timeframe: 3 months vs. 4 months

Change in daily communication performance

Timeframe: 4 months vs. 5 months

Change in daily communication performance

Timeframe: 5 months vs. 6 months

Change in daily communication performance

Timeframe: 6 months vs. 7 months

Change in daily communication performance

Trial details

NCT IDNCT04026581

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-30

View on ClinicalTrials.gov More Amyotrophic Lateral Sclerosis trials

Plain-language summary

Who can participate

Age range

14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in daily communication performance

Timeframe: Baseline vs. 1 month

Change in daily communication performance

Timeframe: 1 month vs. 2 months

Change in daily communication performance

Timeframe: 2 months vs. 3 months

Change in daily communication performance

Timeframe: 3 months vs. 4 months

Change in daily communication performance

Timeframe: 4 months vs. 5 months

Change in daily communication performance

Timeframe: 5 months vs. 6 months

Change in daily communication performance

Timeframe: 6 months vs. 7 months

Change in daily communication performance