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Brain implant aims to give voice to those trapped in silence

NCT ID NCT07698496

Disease control Sponsor: University Hospital, Grenoble Source: ClinicalTrials.gov ↗

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests a fully wireless brain-computer interface (BCI) that aims to decode attempted speech in real time for people with locked-in syndrome (LIS), often caused by ALS or stroke. The implant records brain signals from areas controlling the mouth and throat, then translates them into spoken words via a speech synthesizer. Three adults with LIS will use the device at home, with the goal of producing at least 20 different intelligible speech items after a year of training.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
WIMAGINE intracranial epidural implant with speech synthesizer
What this could lead to
If successful, this could give people with locked-in syndrome a practical, wireless way to speak in real time using only their brain signals.
What could go wrong
This is a very early, small study with only 3 participants. The implant requires brain surgery, which carries risks like infection or neurological complications. Speech decoding may not work well enough for daily use.

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

About 3 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2031

An estimate. End dates often move.

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 65 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: a. Male or female between 18 and 65 years old b. French speaking person c. Person in locked in syndrome with a severe speech disorder following either: i. A subcortical stroke ii. Amyotrophic Lateral Sclerosis. d. Person with stable clinical state (esp. regarding respiratory state) e. Person able to read on a screen (sufficient eye movement control) f. Negative plasma pregnancy test for women of childbearing potential\* g. Highly effective or at least acceptable\*\* contraception for women of childbearing potential. h. Persistence of localizing signals of language function proven by functional MRI. i. Person able to perform a simple BCI task with MEG j. Person with a neuropsychological profile evaluated by psychiatrist as compatible with sustain BCI training k. Informed consent to participate in the obtained using their usual means and code of communication (residual vocalizations, eye-blinking code, pictograms, eye tracking, alphabet chart, etc.), in the presence of their trusted person or curator who is accustomed to communicating with them using this means. l. Person affiliated to the French social security system or beneficiary of such a system Exclusion Criteria: Patients with any of the following criteria cannot be included in this investigation: 1. Severe cognitive disorders assessed after a neuropsychological evaluation 2. Deafness 3. Continuous assisted ventilation 4. Contraindication to intracranial surgery 5. Contra-indication to MRI (1.5T), CT-scan or their related contrast agent injection or MEG examinations. 6. Anatomical brain MRI showing structural abnormalities in the cortical areas of language 7. Functional impairment of language cortical areas on MRI 8. Auditory evoked potential showing hearing impairment 9. Person with a skull shape incompatible with one WIMAGINE implant on each hemisphere 10. Persons referred to in Articles L1125-7 of the Public Health Code and article 64 of MDR(corresponding to all protected persons: pregnant women, women in labor, breastfeeding mothers, minors, persons deprived of liberty by judicial or administrative decision.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis locked-in syndrome speech disorder

As listed by the trial registrant

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

ALS (amyotrophic lateral sclerosis) Locked-in syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre hospitalier Grenoble

    Grenoble, 38000, France

  • Centre hospitalier Nimes

    Nîmes, 30900, France

  • Centre hospitalier saint Etienne

    Saint-Etienne, 42100, France

  • Hôpital Raymond Poincaré Garches

    Garches, 92380, France

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