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Brain zap tailored to each patient could tame tough OCD

NCT ID NCT05160129

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a personalized version of deep brain stimulation (DBS) for people with severe obsessive-compulsive disorder (OCD) that hasn't improved with other treatments. Researchers will adjust the stimulation to target specific brain circuits linked to each patient's symptoms. The goal is to see if this tailored approach works better than standard DBS, which already helps about 60% of patients.

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 device
What this could lead to
If successful, this could make DBS more effective for severe OCD by tailoring stimulation to each patient's brain connections.
What could go wrong
This is a small early-stage study (22 people) testing a new approach, so results may not apply broadly. DBS also carries surgical risks like infection or bleeding.

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 22 people

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

Started

Aug 2021

Expected to finish

Feb 2027

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 years and older

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.

All participants will receive ALIC DBS for OCD. DBS received a Humanitarian Device Exemption (HDE) in 2009 with an indication for bilateral stimulation of the ALIC as an adjunctive treatment to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-refractory OCD in adult patients who have failed at least three SSRIs. Additionally, more stringent criteria have been selected for defining treatment-resistance in this protocol, as indicated below. INCLUSION CRITERIA: * 18 years of age or older * Primary psychiatric diagnosis of Obsessive-Compulsive Disorder (OCD, per DSM-5 criteria) * Meets FDA Humanitarian Device Exemption (HDE) criteria for indication * Has elected to receive clinically indicated DBS for OCD with a directional system outside of this research study, as determined by treating clinician(s) and per current clinical practice * Minimum of a five-year history of treatment-refractory OCD with substantial functional impairment * Failure of an adequate trial of at least three of the following SSRIs: Fluoxetine, Fluvoxamine, Citalopram, Escitalopram, Sertraline, Paroxetine * Failure of an adequate trial of clomipramine * Failure of an adequate trial of one or more of the aforementioned antidepressants in combination with at least one of the following augmentation agents: Haloperidol, Risperidone, Olanzapine, Quetiapine, Ziprasidone, Aripiprazole * Failure of an adequate trial of Cognitive Behavioral Therapy (CBT), defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist * Minimum score of 25 on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at preoperative baseline * Ability to undergo preoperative MRI * English proficiency * Capacity to provide written informed consent * Willing and able to comply with all device operation and study-related procedures EXCLUSION CRITERIA: * Ineligible or unwilling to receive ALIC DBS for OCD * Contraindications for general anesthesia, neurosurgery, or an MRI scan * Neurological disorder or other significant brain pathology, such as moderate / marked cerebral atrophy, stroke, tumor, epilepsy, or previous neurosurgical procedures (excluding cingulotomy, which may be permitted if not contraindicated in the opinion of implanting neurosurgeon) * Unstable medical illness, chronic immunosuppression, and/or considerably reduced life-expectancy * Conditions requiring anticoagulant therapy which cannot be discontinued for the perioperative period, as required * Conditions requiring certain regular MRI scans or diathermy * Currently implanted with a cardiac pacemaker / defibrillator or other implanted electrical device which may interfere with DBS stimulator or the function of which may be impacted by its implantation, in the opinion of evaluating neurosurgeon * Other primary Axis I disorder or history of psychosis, such as schizophrenia, psychosis in the context of depressive or manic episode. * Current or past history within the 6 months prior to DBS implantation of substance abuse or dependence (excluding nicotine and caffeine) * Active suicidal ideation with intent, suicide attempt within the last six months, more than three suicide attempts within the last two years, or serious suicide risk as determined by the study psychiatrists * Axis II disorders which, in the opinion of the study psychiatrist, may increases the risk of DBS to participants or cause study non-compliance * Patients who lack the capacity to for proper device usage and maintenance, in the opinion of the research team * Women who are pregnant

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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.

  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

  • Mount Sinai West

    RECRUITING

    New York, New York, 10019, United States

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