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Could brain zaps wake the unresponsive? tiny trial begins

NCT ID NCT07228286

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early study tests whether implanting electrodes deep in the brain (thalamus) can safely help people with long-term disorders of consciousness. Only 2 participants will be enrolled, and the main goal is to check safety and see if awareness improves using a standard behavioral scale.

What this could mean

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

Active substance
deep brain stimulation (DBS) electrodes implanted in the thalamus
What this could lead to
If successful, this could point toward a new way to help people with long-term consciousness disorders regain some awareness.
What could go wrong
This is a very early, tiny trial (only 2 people) focused on safety. It may not show clear benefit, and brain surgery carries risks like infection or bleeding.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 2 people

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

Started

Nov 2025

Expected to finish

Feb 2029

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 55 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: * Central nervous system injury of any etiology (e.g., cardiac arrest, traumatic brain injury, ischemic stroke, cerebral hemorrhage, encephalitis) that occurred at least 3 months prior to the eligibility phone call * The participant does not exhibit either of the following behaviors every day: meaningful interaction (defined as intelligible speech and ability to follow verbal commands) or functional object use * A CRS-R based diagnosis of DoC; either Unresponsive Wakefulness Syndrome (UWS) or Minimally Conscious State (MCS- or +). * The participant must have a documented health care proxy or court-appointed guardian * Neurologist and neurosurgeon consensus review of most recent clinical MRI (if no MRI, then most recent CT) determines there is no bilateral subcortical injury preventing precise placement of electrodes (e.g., major injuries to the bilateral thalami or severe and bilateral subcortical anatomical distortions). Exclusion Criteria: * \- Pregnant * Contraindication to brain MRI * Due to transportation requirements, participants whose primary residence (Skilled Nursing Facility, Long Term Acute Care, or home) is outside the Greater Boston metropolitan area * Pre-existing psychiatric, neurological or medical condition that makes the patient, in the opinion of the study team, a poor surgical candidate (e.g., neurodegenerative disorder, significant cardiopulmonary disorder, need for chronic anticoagulation) * Structural abnormality of the chest wall, neck, brain, or skull that makes safe placement of the electrodes, in the opinion of the study team, infeasible or prone to complication * Neurologist and neurosurgeon consensus review of most recent clinical MRI (if no MRI, then most recent CT) determines there is no bilateral diffuse injury to the basal ganglia * Medical contraindications to surgery including: * Chronic infection * Coagulopathy (INR \> 1.5, aPTT 45 sec, platelet count \< 100 x 103 / uL) * Poorly controlled blood pressure (\> 2 episodes during screening phase of blood pressure \> 180/110 sustained on repeated measurements) and evidence of cardiovascular disease * Participation in another drug, device or biological trial within 90 days * Current implanted stimulation device (e.g., pacemaker, defibrillator, spinal cord stimulator, deep brain stimulator) * Anticoagulant or anti-platelet medication that cannot be safely stopped for \> 2.5 weeks in the peri-operative period

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Conditions

The condition(s) this trial relates to.

brain injury Consciousness Disorders

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

More trials for these conditions

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