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Completed
NCT06521736
Brain-computer Interface Commercial Readiness
Conditions: Non-Verbal Communication, Degenerative Neurologic Disease
Sex: All
Ages: 14 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 47
Sponsor: Kendrea Garand
Location: University of Pittsburgh Pittsburgh Pennsylvania
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 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.
Eligibility Criteria
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
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT06521736). StuddyBuddy aggregates publicly available trial information.