Status:
ENROLLING_BY_INVITATION
Brain-computer Interface Commercial Readiness
Lead Sponsor:
Kendrea Garand
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Michigan
Conditions:
Non-Verbal Communication
Degenerative Neurologic Disease
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Our clinical trial focuses on 8 Alternative Communication Brain-Computer Interface (AAC-BCI) users but involves a team of support participants with different roles: an industry partner's consultant, a...
Eligibility Criteria
Inclusion
- 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
- Receiving speech therapy from a licensed speech language pathologist
- Has been assessed for and currently using a speech generating device as a means of communication
- Has a diagnosis resulting in minimal movement interfering with direct selection to a keyboard or AAC display
- Has a support person who is comfortable with technology, willing to learn a new technology system and is available to set-up the AAC-BCI daily at the user's request.
- In-home internet access
- Environment that is suitable for setting up the in-home AAC-BCI system
- Individuals aged 14 or older
- Speaks English
- For Support Persons
- Speaks English
- Willing to be trained to support the AAC-BCI system for the person with a severe disability who uses a speech generating device for communication
- Willing to set-up and clean the AAC-BCI system for at minimum of 10 hours a week up to daily use
- Willing to contact technical support when/if needed for AAC-BCI system
- Willing to complete support person diary documentation
- Able to access In-home internet
- Is 18 years or older
- For PRC Regional Consultants
- 2 or more years of experience as a PRC regional consultant
- 2 or more years of experience providing support to speech-language pathologists working with patients with complex communication needs and movement disorders
- 2 or more years of experience providing support to customers with complex communication needs and movement disorders
- received training on AAC-BCI system
- For Clinicians:
- Licensed speech-language pathologist with AAC experience -Currently treating clients who require AAC support-
- Received AAC-BCI training
Exclusion
- For AAC-BCI Users:
- Does not own or use a speech generating device
- Unable to participate during the scheduled time periods
- History of photosensitive epilepsy
- History of uncorrectable hearing loss
- Unable to participate during scheduled times
- Has a history of open scores on the scalp
- Does not speak English
- For Support Persons:
- Unable to participate during the scheduled time periods
- Can not attend the in-home training sessions
- -Does not speak English
- Does not know how to use the internet
- For PRC Regional Consultants:
- Unable to recommend a speech-language pathologist in their territory
- Unable to recommend an individual with a complex communication and movement disorder.
- For Clinicians:
- Does not have a certificate of clinical competence from the American Speech Language Hearing Association (ASHA)
- Unable to recommend a client to participate with a support person for the clinical trial
- Unable to participate in a 2-day training on the AAC-BCI system
- Unable to participate during the scheduled time periods
Key Trial Info
Start Date :
September 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06521736
Start Date
September 13 2024
End Date
April 30 2026
Last Update
October 3 2025
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260