Brain-Computer Interface for Neurodegenerative Disease

Overseen By Jane Huggins, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Katharine Katya Joan Hill

Disqualifiers: No speech device, Epilepsy, Hearing loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the commercial readiness of an Augmentative and Alternative Communication Brain-Computer Interface (AAC-BCI) device for people with minimal movement who benefit from expressive communication technology. Our clinical trial focuses on up to 8 AAC-BCI users but involves a team of support participants with different roles: an industry partner's consultant, a speech language pathologist (SLP), and the user's in-home support person. Patient and team reported outcome measures data will be collected on usage, performance, reliability and comfort along with performance data of using the AAC-BCI device in the home.

Research Team

Katharine J Hill, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for individuals with neurodegenerative diseases or nervous system disorders who have limited movement and could benefit from technology that helps them communicate. Participants will use an AAC-BCI device at home, supported by a team including a consultant, speech therapist, and in-home support person.

Inclusion Criteria

For augmentative and alternative communication, brain-computer interface (AAC-BCI) Users:

Natural speech does not meet daily communication needs requiring the use of a speech generating device

Has been assessed for and currently using a speech generating device as a means of communication

Exclusion Criteria

For AAC-BCI Users:

Does not own or use a speech generating device

I cannot participate in the study during the scheduled times.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Calibration

Initial set-up, calibration, and training sessions with AAC-BCI device, including EEG and logfile data collection

1 week

2 visits (in-person)

Home Use and Monitoring

Participants use the AAC-BCI device at home for at least 10 hours a week, with monthly home visits and weekly follow-up calls for data collection

6 months

Monthly home visits, weekly follow-up calls

Follow-up

Participants complete a survey to rate the overall commercial readiness of the AAC-BCI device

1 week

Treatment Details

Interventions

• AAC-BCI device

Trial Overview The study tests the readiness of an AAC-BCI device for market release by assessing its usage, performance, reliability, and comfort when used by patients in their homes. It involves both patient feedback and objective performance data collection.

Participant Groups

Group I: Testing commercial readiness of an AAC-BCI device Experimental Treatment 1 Intervention

Participants with severe movement disabilities will use the augmentative and alternative communication, brain-computer interface (AAC-BCI) device at least 10 hours a week in their homes receiving supported from a caregiver, speech language pathologist and consultant and rate the intervention on user satisfaction, performance, reliability, comfort and overall readiness for commercialization.

Who Is Running the Clinical Trial?

Katharine Katya Joan Hill

Lead Sponsor

Trials

1

Recruited

40+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

PRC

Collaborator

Trials

1

Recruited

40+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+