Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder

NCT05160129 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY-21-001251R01MH123542-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Obsessive Compulsive Disorder (OCD)

Keywords

Deep Brain Stimulation (DBS); Obsessive Compulsive Disorder (OCD); Anterior Limb of Internal Capsule (ALIC); Circuit Modulation

Outcome Measures

Primary Outcomes (1)

• Change in Yale Brown Obsessive Compulsive Scale (Y-BOCS)

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

  Pre-surgical baseline, monthly up to 12 months postoperative

Secondary Outcomes (10)

• Investment Task

  Pre-surgical baseline, bimonthly up to 12 months postoperative

• Reversal Task

  Pre-surgical baseline, bimonthly up to 12 months postoperative

• Stop Signal Task

  Pre-surgical baseline, bimonthly up to 12 months postoperative

• Tractography pathway activation models (Diffusion-weighted-imaging)

  Baseline: Pre-surgery

• Deep brain stimulation evoked potentials (EEG)

  postoperative months 0, 6, 12

Study Arms (1)

Circuit-selective DBS

EXPERIMENTAL

People suffering from severe obsessive-compulsive disorder (OCD)

Device: Selective focal stimulation of ALIC-pathways

Interventions

Selective focal stimulation of ALIC-pathways DEVICE

DBS will be applied selectively to different electrode contacts/ segments to evaluate clinical, behavioral, and electrocortical responses of specific pathways within the ALIC.

Circuit-selective DBS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Mount Sinai West

New York, New York, 10019, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Martijn Figee

  Icahn School of Medicine and Mount Sinai

  PRINCIPAL INVESTIGATOR

• Ki Sueng Choi

  Icahn School of Medicine and Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abby Kiros

CONTACT

212-523-8279; abigeal.kiros@mssm.edu

Martijn Figee

CONTACT

martijn.figee@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 16, 2021
• Study Start: August 13, 2021
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. To achieve aims in the approved proposal. Proposals should be directed to Sonia.olson@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website.

Locations

US (1)