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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06521736). StuddyBuddy aggregates publicly available trial information.