Brain-computer Interface Commercial Readiness
Completed · Not applicable
Conditions studied: Non-Verbal Communication, Degenerative Neurologic Disease
In brief
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.
Key facts
- Study ID
- NCT06521736
- Run by
- Kendrea Garand
- People needed
- 47
- Starts
- 2024-09-13
- Expected to finish
- 2026-04-30
- Last updated by the study team
- 2026-06-12
Who can join
Age: 14 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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-
You may not qualify if…
- 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
Where it is running
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.