Brain-computer Interface Commercial Readiness

NCT06521736 | Enrolling By Invitation DMC FDA Device

• 2 other identifiers: STUDY240401692SB1DC015142-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Non-Verbal Communication; Degenerative Neurologic Disease

Keywords

speech generating device; user-satisfaction; performance

Outcome Measures

Primary Outcomes (1)

• Commercial readiness of augmentative and alternative communication brain-computer interface (AAC-BCI) system.

  Stakeholder participants agree "yes" that the Alternative Communication Brain-Computer Interface (AAC-BCI) system is ready for product release with an average combined agreement of 70% on a binary yes/no scale.

  6 months

Secondary Outcomes (4)

• Alternative Communication Brain-Computer Interface (AAC-BCI) system user-satisfaction

  6 months

• Alternative Communication Brain-Computer Interface (AAC-BCI) system performance

  6 months

• Alternative Communication Brain-Computer Interface (AAC-BCI) system reliability

  6 months

• Alternative Communication Brain-Computer Interface (AAC-BCI) system comfort

  6 months

Study Arms (1)

Testing commercial readiness of an AAC-BCI device

EXPERIMENTAL

Participants with severe movement disabilities will use the augmentative and alternative communication, brain-computer interface (AAC-BCI) device at least 10 hours a week in their homes receiving supported from a caregiver, speech language pathologist and consultant and rate the intervention on user satisfaction, performance, reliability, comfort and overall readiness for commercialization.

Device: AAC-BCI device

Interventions

AAC-BCI device 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.

Testing commercial readiness of an AAC-BCI device

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Kendrea Garand: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• University of Michigan: collaborator
• PRC: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (4)

• Hill K, Kovacs T, Shin S. Reliability of brain-computer interface language sample transcription procedures. J Rehabil Res Dev. 2014;51(4):579-90. doi: 10.1682/JRRD.2013.05.0102.

  PMID: 25144171 BACKGROUND

• Hill K, Kovacs T, Shin S. Critical issues using brain-computer interfaces for augmentative and alternative communication. Arch Phys Med Rehabil. 2015 Mar;96(3 Suppl):S8-15. doi: 10.1016/j.apmr.2014.01.034.

  PMID: 25721552 BACKGROUND

• Huggins JE, Alcaide-Aguirre RE, Hill K. Effects of text generation on P300 brain-computer interface performance. Brain Comput Interfaces (Abingdon). 2016;3(2):112-120. doi: 10.1080/2326263X.2016.1203629. Epub 2016 Jul 4.

  PMID: 28261630 BACKGROUND

• Hill K, Huggins J, Woodworth C. Interprofessional Practitioners' Opinions on Features and Services for an Augmentative and Alternative Communication Brain-Computer Interface Device. PM R. 2021 Oct;13(10):1111-1121. doi: 10.1002/pmrj.12525. Epub 2021 Jan 23.

  PMID: 33236859 BACKGROUND

MeSH Terms

Conditions

Nonverbal Communication; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Communication; Behavior; Nervous System Diseases

Study Officials

• Katharine J Hill, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: This clinical trial employs a Single Group Assignment model to evaluate the commercial readiness of an Augmentative and Alternative Communication Brain-Computer Interface (AAC-BCI) device for individuals with minimal movement capabilities. The study involves up to 8 AAC-BCI users diagnosed with conditions such as late-stage amyotrophic lateral sclerosis (ALS), brainstem stroke, or severe quadriplegic cerebral palsy, supported by an industry partner's consultant, a speech language pathologist (SLP), and the user's in-home support person. Participants will be trained on the device, using it at least 10 hours per week at home. The primary objective is to achieve 80% stakeholder agreement on the device's readiness for product release. Secondary objectives focus on safety, performance, and user satisfaction. The study's design ensures comprehensive data collection on the AAC-BCI system's usability and performance, providing critical insights for future development and larger-scale trials.

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 26, 2024
• Study Start: September 13, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: May 2026 without deletion of shared data.
• Access Criteria: Data obtained through this study may be provided to qualified researchers with academic interest in electroencephalography (EEG) brain-computer interfaces for communication. Data or samples shared will be coded, with no private health information (PHI) included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

Locations

US (1)