Actively Recruiting
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
N/A
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
Researchers are studying deep brain stimulation (DBS) as a treatment for adults with severe obsessive-compulsive disorder (OCD) who have not improved after multiple treatments over several years. This study focuses on a specific brain area called the anterior limb of the internal capsule (ALIC), where DBS has shown benefits for about 60% of patients. The goal is to personalize DBS by targeting precise brain circuits linked to each patient's OCD symptoms to improve treatment outcomes. Participants will receive bilateral DBS implants in the ALIC region using directional segmented electrodes. These electrodes allow for focused stimulation of five specific brain pathways identified through detailed pre-surgery brain scans, including high-definition 7T MRI. The personalized approach aims to activate brain circuits related to OCD symptoms while minimizing side effects. After surgery, patients will have routine visits to adjust stimulation settings and will undergo EEG recordings and behavioral testing at multiple points up to 12 months. During the study, participants will complete various behavioral tasks every two months and have monthly assessments measuring OCD symptoms, mood, anxiety, impulsiveness, mania, and suicide risk. Researchers will track changes using the Yale Brown Obsessive Compulsive Scale (Y-BOCS) and other clinical scales. The study also includes brain imaging and EEG to understand how stimulation affects brain activity. Safety and treatment effects will be monitored throughout the year-long follow-up period.
CONDITIONS
Brief Title
Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Primary psychiatric diagnosis of Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria
- Meets FDA Humanitarian Device Exemption criteria for bilateral ALIC DBS as an adjunctive treatment
- Has chosen to receive clinically indicated DBS for OCD with a directional system
- Minimum five-year history of treatment-refractory OCD with significant functional impairment
- Failed adequate trials of at least three SSRIs including Fluoxetine, Fluvoxamine, Citalopram, Escitalopram, Sertraline, or Paroxetine
- Failed an adequate trial of clomipramine
- Failed an adequate trial of one or more antidepressants combined with agents like Haloperidol, Risperidone, Olanzapine, Quetiapine, Ziprasidone, or Aripiprazole
- Failed an adequate trial of Cognitive Behavioral Therapy with at least 25 hours of documented exposure and response prevention
- Minimum score of 25 on Yale-Brown Obsessive Compulsive Scale at preoperative baseline
- Ability to undergo preoperative MRI
- Proficiency in English
- Capacity to provide written informed consent
- Willing and able to comply with all device operation and study procedures
You will not qualify if you...
- Ineligible or unwilling to receive ALIC DBS for OCD
- Contraindications for general anesthesia, neurosurgery, or MRI scan
- Neurological disorders or significant brain pathology such as cerebral atrophy, stroke, tumor, epilepsy, or previous neurosurgical procedures (except permitted cingulotomy)
- Unstable medical illness, chronic immunosuppression, or reduced life expectancy
- Need for anticoagulant therapy that cannot be stopped during surgery
- Requirement for regular MRI scans or diathermy
- Presence of cardiac pacemaker, defibrillator, or other implanted electrical device interfering with DBS
- Other primary Axis I disorders or history of psychosis like schizophrenia
- Substance abuse or dependence within 6 months before DBS implantation (excluding nicotine and caffeine)
- Active suicidal thoughts with intent, recent suicide attempt, multiple attempts, or serious suicide risk
- Axis II disorders increasing risk or non-compliance
- Lack capacity for proper device use and maintenance
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (surgery day)
Participants undergo bilateral implantation of deep brain stimulation (DBS) leads into the ALIC brain region and an internal pulse generator device is implanted to deliver stimulation.
1 surgical visit
Duration - Up to 12 months
Participants receive personalized, circuit-specific DBS targeting five ALIC pathways with routine clinical visits for optimizing stimulation parameters and monitoring clinical effects.
Monthly visits and bimonthly behavioral testing during stimulation
Duration - 12 months post-implantation
Participants undergo EEG recordings at stimulation initiation and after 6 and 12 months to assess evoked potentials and clinical outcomes.
3 EEG visits (at 0, 6, and 12 months post-surgery)
Trial Site Locations
Total: 1 location
1
Mount Sinai West
New York, New York, United States, 10019
Actively Recruiting
Research Team
A
Abby Kiros
M
Martijn Figee
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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