Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Mount Sinai West
RECRUITING
New York
Contact Information
Primary
Abby Kiros
abigeal.kiros@mssm.edu
212-523-8279
Backup
Martijn Figee
martijn.figee@mssm.edu
Time Frame
Start Date: 2021-08-13
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 20
Treatments
Experimental: Circuit-selective DBS
People suffering from severe obsessive-compulsive disorder (OCD)
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov