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ENROLLING BY INVITATION

NCT06521736

Brain-computer Interface Commercial Readiness

Sponsor: Kendrea Garand

View on ClinicalTrials.gov

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.

Official title: Compatibility Between Brain-Computer Interface and High Efficiency Augmentative and Alternative Communication Systems: Commercial Readiness

Key Details

Gender

All

Age Range

14 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-09-13

Completion Date

2026-04-30

Last Updated

2025-10-03

Healthy Volunteers

Yes

Conditions

Non-Verbal Communication Degenerative Neurologic Disease

Interventions

DEVICE

AAC-BCI device

Participants without speech and severe movement disorders will be trained on the augmentative and alternative communication, brain-computer interface (AAC-BCI) system, using it for at least 10 hours per week in their homes for communication and other control functions. Participants will have daily support for using the AAC-BCI from trained caregivers along with intervention support from consultants and speech language pathologists.

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

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States