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Brain pacemaker could tame tough OCD

NCT ID NCT06660225

Disease control Sponsor: Nader Pouratian 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 if deep brain stimulation (DBS) can help people with severe obsessive-compulsive disorder (OCD) that hasn't improved with other treatments. Ten participants will have a device implanted in their brain and be randomly assigned to receive real or sham stimulation. Researchers will track symptom changes and safety over several years to see if DBS is effective.

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

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jan 2031

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

22 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: * Patients with a diagnosis of obsessive-compulsive disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria * Severe OCD assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS) with a score of more than 27 * Refractory OCD; severe symptoms and impairment for more than 5 years despite pharmacological and psychological treatment. * Have failed to improve following treatment with at least two serotonin transport inhibitors and one augmenting agent taken for an adequate time period. * Having failed to improve despite adequate cognitive behavioral therapy, as evaluated by the study psychiatrist * Patients between 22 and 75. * Ability to understand and sign written informed consent by the patient. Exclusion Criteria: * Diagnosis of severe major depression disorder (MDD) with psychotic features. * Significant suicidal risk \[Hamilton Depression scale item 3 (suicide)\>2\]. * Comorbidity with any primary Psychotic Disorder, Post-Traumatic Stress Disorder (PTSD), or Eating Disorder. * History of substance or alcohol dependence or abuse in the preceding 12 months. * Significant cognitive decline, measured by Mini-Mental State Examination (MMSE \<26) and Montreal Cognitive Assessment (MoCA; \<24). * Any other current clinical significant neurological disorder or medical illness affecting brain function, other than a tic disorder. * Any clinically significant abnormality on preoperative MRI that would affect the safety of the surgical procedure in the opinion of the study neurosurgeon. * Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors, or other medical risk factors for surgery. * Pregnancy.

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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

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

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

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