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Brain zaps for schizophrenia? tiny trial tests DBS when meds fail

NCT ID NCT07369401

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether deep brain stimulation (DBS) — a device that sends electrical pulses to specific brain areas — can help people with schizophrenia that hasn't improved with medication. Ten adults aged 18-55 will have electrodes implanted in two brain regions and receive different stimulation patterns over 24 weeks. The goal is to see if symptoms improve enough to make a real difference.

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 it works, this could point toward a new option for people with schizophrenia that doesn't respond to medication.
What could go wrong
This is a very small early study with only 10 people, so results may not apply widely. Brain surgery carries risks like infection or bleeding, and the benefit is uncertain.

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 10 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 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 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: * Aged 18-55 years (inclusive) at the time of signing the informed consent form, male or non-pregnant female; * Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for schizophrenia; * Schizophrenia disease course ≥ 5 years before screening; * Meets the 2016 TRRIP criteria for refractory/ultra-refractory schizophrenia: previous treatment with ≥ 2 non-clozapine antipsychotics at adequate dose (≥ 600mg/day chlorpromazine equivalent) and duration (≥ 12 weeks) with no response or intolerance, or clozapine at adequate dose (≥ 300mg/day or plasma concentration ≥ 350ng/ml) and duration (≥ 12 weeks) with no response or intolerance, plus moderate or greater symptom severity; * PANSS total score ≥ 70 at screening and baseline; * No changes in medication regimen in the past 2 months; * The patient and their guardian have been fully informed and signed the informed consent form. Exclusion Criteria: * Comorbid with epilepsy, severe cognitive impairment (Mini-Mental State Examination \[MMSE\] score \< 10), organic mental disorder, paranoid personality disorder, mental retardation, or addiction (other than nicotine); * Has implanted devices such as cochlear implants or cardiac pacemakers, or has undergone surgery that may affect the trial within 6 months; * Has contraindications to DBS implantation and is deemed unsuitable for surgery by the investigator; * Has participated in other drug/medical device clinical trials within 3 months before screening; * Confirmed HIV-positive; * Pregnant/lactating women, women of childbearing age with positive HCG/urine pregnancy test at screening, those unable to use effective contraception during the trial, or those planning to conceive within 3 months after trial initiation; * Other conditions deemed unsuitable for participation by the investigator.

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Conditions

The condition(s) this trial relates to.

Schizophrenia, Treatment-Resistant treatment-refractory schizophrenia

As listed by the trial registrant

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

How to take part

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

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