Brain zaps for schizophrenia? tiny trial tests DBS when meds fail
NCT ID NCT07369401
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
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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
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
More trials for these conditions
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