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Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder

This study is for people with severe Obsessive Compulsive Disorder (OCD) whose symptoms haven't improved with other treatments. It's testing a type of Deep Brain Stimulation (DBS) that targets a specific brain area called the anterior limb of the internal capsule (ALIC). DBS involves placing small wires in the brain that deliver electrical pulses to help control symptoms. This study aims to make DBS even better by customizing the stimulation for each person, focusing on specific brain connections within the ALIC that are linked to individual OCD symptoms. Researchers will use special brain scans to create a personalized plan for where to place the DBS wires and how to deliver the stimulation. The main goal is to see if this personalized approach improves your OCD symptoms, measured by changes in your Yale Brown Obsessive Compulsive Scale (Y-BOCS) scores over 12 months. All participants will receive ALIC DBS for OCD. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 22 participants. All participants will receive ALIC DBS.
What's involved
You will undergo surgery to implant DBS leads and a device under your skin. Before surgery, you'll have a high-definition 7T MRI brain scan, and after surgery, you'll have monthly clinical visits for up to 12 months to adjust the DBS settings and monitor your symptoms.
Compensation
Not stated in the trial record.
Follow-up
Your OCD symptoms will be measured monthly for up to 12 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05160129

Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder

Recruiting
NAAges 18+InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~22 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Selective focal stimulation of ALIC-pathways

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Measured over Pre-surgical baseline, monthly up to 12 months postoperative

Conditions

Obsessive Compulsive Disorder (OCD)

Explore related trials

Obsessive Compulsive Disorder

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Martijn Figee · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine and Mount Sinai
  • Ki Sueng Choi · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine and Mount Sinai

Who to contact

Abby Kiros
[email protected]
212-523-8279
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Yale Brown Obsessive Compulsive Scale (Y-BOCS)Pre-surgical baseline, monthly up to 12 months postoperative

    This scale measures change in OCD symptom severity. Full scale from from 0 - 40 with higher score indicating more severe symptoms.