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Brain pacemaker shows promise for severe OCD

NCT ID NCT04967560

Disease control Sponsor: Shanghai Mental Health Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 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 severe obsessive-compulsive disorder (OCD) that hasn't improved with standard treatments. Participants receive a DBS implant targeting two brain regions linked to OCD. Half get real stimulation, half get sham (no stimulation) for three months, then all can receive real stimulation. The goal is to see if DBS significantly reduces OCD symptoms and improves quality of life.

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 offer a new treatment option for people with severe OCD that hasn't responded to standard therapies.
What could go wrong
This is a relatively small, early-stage trial. The surgery carries risks like infection or bleeding, and the stimulation may cause side effects. It's not yet proven to work for everyone.

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

60 people

The number who actually took part.

Started

Jul 2021

Finished

Jan 2024

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 65 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 18-65 years old; * a diagnosis of OCD based on The Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5); * suffered from severe OCD symptoms over 5 years with substantial functional impairment; * the Y-BOCS total score ≥ 25; * met the criteria of treatment refractory. Treatment refractory is defined as failed 1) at least three adequate therapeutic trials of serotin reuptake inhibitors (SRIs), with clomipramine being one of the SRIs trials, 2) the use of at least two atypical antipsychotics as augmenting agents, 3) at least 12 sessions of therapist-guided cognitive-behavioral therapy while on a therapeutic dose of an SRIs. These patients have "failed" treatment by demonstrating \<25% reduction of Y-BOCS scores or, despite \>25% reduction in YBOCS score, by still experiencing significant impairment from their illness. Exclusion Criteria: * a history of current or past diagnosis of any psychosis according to DSM-5 except for OCD * any clinical significant neurological disorder, traumatic brain injury, dementia, or medical illness * any contradiction of neurosurgery * any current or unstably remitted substance abuse or dependence * women who are pregnant or preparing for pregnant * severe suicide risk and tendency according to the investigators' judgements * participate in any other clinical trials within three months (except for registered studies).

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Conditions

The condition(s) this trial relates to.

obsessive-compulsive disorder

As listed by the trial registrant

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

Obsessive-compulsive disorder

Contacts and locations

Locations

  • Brains Hospital of Hunan Province

    Changsha, Hunan, China

  • Changhai Hospital

    Shanghai, Shanghai Municipality, China

  • Huashan Hospital

    Shanghai, Shanghai Municipality, China

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200030, China

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, China

  • West China Hospital

    Chengdu, Sichuan, China

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