RECRUITING

Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder

Quick Facts

Study Start:2021-08-13

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05160129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Abby Kiros

CONTACT

212-523-8279

abigeal.kiros@mssm.edu

Martijn Figee

CONTACT

martijn.figee@mssm.edu

Principal Investigator

Martijn Figee

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine and Mount Sinai

Ki Sueng Choi

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine and Mount Sinai

Study Locations (Sites)

Mount Sinai West

New York, New York, 10019

United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-13

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2021-08-13

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Obsessive Compulsive Disorder (OCD)