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Brain implant gives voice to the locked-in

NCT ID NCT02224469

Knowledge-focused Sponsor: UMC Utrecht Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new brain implant for people with locked-in syndrome, who are awake but cannot move or speak. The implant records brain signals from the surface of the brain and sends them wirelessly to a computer, allowing the person to control a communication device. Six participants tried the system at home to see if they could reliably use it to spell sentences.

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

6 people

The number who actually took part.

Started

Sep 2015

Finished

Feb 2024

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Age 18 - 75 * Locked-in status (i.e. severely paralyzed with communication problems) * in case of trauma or stroke: at least 1 year after the event * in case of a neuromuscular disease: slow progression allowed * Rudimentary form of communication possible (e.g. through assistive technology, eye blinks or eye movements, severely impaired speech) * Mentally and physically capable of giving informed consent * Lives in or close to the Netherlands * MR compatible * able to lie flat in the scanner * no metal objects in or attached to the body * no claustrophobia * Visus (largely) intact * Cognition intact (IQ\>80) * Compatible with implantation procedure * good respiratory function or stable respiratory situation using ventilation assistance Exclusion Criteria: * Strong and frequent spasms * Vital indication for blood thinners * Current brain tumor or history of tumor resection * Quick medical or neurological deterioration * Patients who are considered legally incapable (and who therefore will not be able to give informed consent) * Current or recent psychiatric disorder * Catabolic state * Allergy to the materials of the implant

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Conditions

The condition(s) this trial relates to.

locked-in syndrome

As listed by the trial registrant

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

Locked-in syndrome

Contacts and locations

Locations

  • University Medical Center

    Utrecht, 3584CX, Netherlands

More trials for these conditions

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