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Brain-computer Interface Commercial Readiness

NCT06521736 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-05-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • University of Michigan

    collaborator OTHER

  • PRC

    collaborator UNKNOWN

  • Kendrea Garand

    lead OTHER

Principal Investigators

  • Katharine J Hill, PhD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-13
Primary Completion
2026-04-30
Completion
2026-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06521736 on ClinicalTrials.gov