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Zap to wake? new brain stimulation trial hopes to rouse patients from Coma-Like states

NCT ID NCT06896279

Symptom relief Sponsor: Huashan Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new, non-invasive brain stimulation method called temporal interference stimulation to see if it can safely help people with severe consciousness disorders (like a coma or vegetative state) regain awareness. The study will enroll 20 adults aged 18-75 who have been in a minimally conscious or vegetative state for at least 28 days. Researchers will measure improvements using a standard consciousness scale and compare results to a sham (fake) stimulation group.

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 20 people

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

Started

Apr 2025

Expected to finish

May 2026

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 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: * Severe consciousness disorder patients aged 18 to 75 years old, regardless of gender; * Patients with severe consciousness disorders, namely a minimally conscious state or vegetative state that lasts for 28 days or more; * Patients with normal body temperature, stable vital signs, spontaneous breathing, tracheotomy without the use of a metal cannula and with a small amount of sputum, and who are eligible for magnetic resonance imaging (MRI) examination; * Written informed consent obtained from the patient's family members in advance. Exclusion Criteria: * Individuals with a previous history of significant neuropsychiatric and other major disorders such as those involving the heart, lung, liver, and kidney; * Those who have undergone V-P shunt or Ommaya reservoir implantation and other procedures that may influence the analysis of magnetic resonance scanning signals; * Patients who are scheduled for V-P shunt or Ommaya reservoir implantation in the near future; * Pregnant women; * Those who have participated in other drug or device clinical trials; * Patients with poorly controlled epilepsy in the recent period; * Those with infections at the TI stimulation site or compromised skin integrity at the electrode placement site; * Those currently taking medications prone to inducing epilepsy, such as quinolone drugs; * Those with intracranial infections, intracranial tumors, or metallic objects within the cranium; * Those allergic to electrode gel or adhesives; * Those with implanted electronic devices within the body; * Those with severe cardiac disorders and those equipped with cardiac pacemakers.

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Conditions

The condition(s) this trial relates to.

Consciousness Disorders

As listed by the trial registrant

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

Disorder of consciousness Temporal interference stimulation

How to take part

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

  1. The places running it

    2 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

  • Department of Neurosurgery, Huashan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • Department of neurological rehabilitation, Shanghai First Rehabilitation Hospital, Tongji University

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

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