Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05160129

Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-06-12

20

Participants Needed

1

Research Sites

241 weeks

Total Duration

On this page

Sponsors

I

Icahn School of Medicine at Mount Sinai

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Deep brain stimulation (DBS) is an effective treatment for people suffering from severe obsessive-compulsive disorder (OCD) whose symptoms have failed to improve after years and multiple methods of intervention. An effective DBS target for OCD is the anterior limb of the internal capsule (ALIC) brain region. On average 60% of all OCD patients have a clinically significant response to ALIC DBS. However, ALIC DBS may become even more effective with the ability to predict which specific ALIC connections in the brain need to be stimulated for each individual OCD patient. This study therefore investigates personalized stimulation to the ALIC that allows for precise modulation of brain circuits associated with individual OCD symptoms. The study aims to specify the ideal anatomical target for ALIC DBS for maximum therapeutic benefit in each patient.

CONDITIONS

Official Title

Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Elected to receive clinically indicated DBS for OCD with a directional system outside of this research study
  • Minimum of a five-year history of treatment-refractory OCD with substantial functional impairment
  • Failure of an adequate trial of at least three SSRIs: Fluoxetine, Fluvoxamine, Citalopram, Escitalopram, Sertraline, Paroxetine
  • Failure of an adequate trial of clomipramine
  • Failure of an adequate trial of one or more antidepressants combined with one or more 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
Not Eligible

You will not qualify if you...

  • Ineligible or unwilling to receive ALIC DBS for OCD
  • Contraindications for general anesthesia, neurosurgery, or MRI scan
  • Neurological disorder or significant brain pathology such as moderate/marked cerebral atrophy, stroke, tumor, epilepsy, or previous neurosurgical procedures (except permitted cingulotomy)
  • Unstable medical illness, chronic immunosuppression, or significantly reduced life expectancy
  • Conditions requiring anticoagulant therapy that cannot be stopped for surgery
  • Conditions requiring certain regular MRI scans or diathermy
  • Implanted cardiac pacemaker, defibrillator, or other electrical device that may interfere with or be affected by DBS
  • Other primary Axis I disorders or history of psychosis including schizophrenia or mood-related psychosis
  • Substance abuse or dependence within 6 months before DBS implantation (excluding nicotine and caffeine)
  • Active suicidal ideation with intent, recent suicide attempts, or serious suicide risk
  • Axis II disorders increasing risk of DBS or causing non-compliance
  • Lack of capacity for proper device use and maintenance
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mount Sinai West

New York, New York, United States, 10019

Actively Recruiting

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Research Team

A

Abby Kiros

CONTACT

M

Martijn Figee

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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