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Brain zaps for schizophrenia? new trial tests deep brain stimulation

NCT ID NCT07671261

Disease control Sponsor: Ruijin 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether deep brain stimulation (DBS) can help people with schizophrenia whose symptoms haven't improved with medication. First, doctors map the brain using electrodes to find the problem areas. Then, they implant a device that delivers mild electrical pulses to those spots. The trial involves 46 participants and will track symptom changes over 12 months.

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) device
What this could lead to
If successful, this could offer a new treatment option for people with schizophrenia that hasn't improved with standard therapies.
What could go wrong
This is an early-stage trial with only 46 participants, so results may not apply to everyone. Brain surgery carries risks like infection or bleeding, and the treatment may not work for all.

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 46 people

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

Started

Aug 2025

Expected to finish

Dec 2028

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: * Meets the International Classification of Diseases, 10th Revision (ICD-10) diagnostic criteria for schizophrenia. * Male or female, aged 18 to 55 years, with stable vital signs. * Currently presents with prominent psychotic symptoms, assessed as moderate or severe by the Positive and Negative Syndrome Scale (PANSS) or other equivalent scales. * Exhibits impaired social functioning, assessed as moderate or severe impairment by the Social and Occupational Functioning Assessment Scale (SOFAS) or other equivalent scales. * Has a history of sequential treatment with at least two antipsychotic medications of different chemical structures known for strong efficacy against positive symptoms. Treatment must have been at an adequate dose and for an adequate duration (continuous treatment at a therapeutic dose for more than 6 weeks per medication), with good treatment adherence. * Has been on a stable antipsychotic medication regimen for at least one month prior to enrollment. * Capable and willing to provide written informed consent. * Demonstrates good compliance and is able to cooperate with all follow-up procedures. Exclusion Criteria: * Diagnosed with any psychiatric disorder other than schizophrenia. * Presence of a severe personality disorder. * History of severe neurological diseases, such as seizures or hemorrhagic stroke. * Presence of structural brain abnormalities. * Previous history of stereotactic neurosurgery. * Contraindications to general anesthesia or stereotactic neurosurgery. * Any current or anticipated condition-including medical, psychological, social, familial support, or geographical factors-that might compromise patient safety or interfere with successful participation in the study.

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Conditions

The condition(s) this trial relates to.

Psychotic Disorders schizoaffective disorder schizophrenia

As listed by the trial registrant

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

Schizo affective disorder Schizophrenia disorders

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

  • Ruijin Hospital, Shanghai JiaoTong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

More trials for these conditions

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