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Brain-Computer device nears market for Non-Verbal patients

NCT ID NCT06521736

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a brain-computer interface (BCI) device is ready for commercial use to help people with minimal movement communicate. Researchers worked with 8 device users, plus speech therapists and support staff, to evaluate how well the device worked at home. The goal was to see if the device was reliable, comfortable, and easy enough to use for everyday communication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

47 people

The number who actually took part.

Started

Sep 2024

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.