DBS for Obsessive-Compulsive Disorder

NCT02773082 | Recruiting FDA Device

• 1 other identifier: HSC-MS-09-0520
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

There are two primary approaches to the treatment of OCD, pharmacotherapy and cognitive behavior therapy (CBT). Lack of therapeutic success with one approach leads to trials of the alternative approach or a combination of the two. A rarely used third therapy approach, appropriate for only the most severely afflicted and treatment resistant patients, is neurosurgical ablation of certain brain regions involved in mood and anxiety. The neurosurgical ablation procedures are irreversible in nature, and involve the destruction of specific volumes of brain tissue through various controlled means. Surgical procedures include cingulotomy, subcaudate tractotomy, limbic leucotomy which is a combination of the first two procedures and capsulotomy. DBS therapy is an alternative to neurosurgical procedures, specifically anterior capsulotomy, for patients with chronic, severe OCD which has proven resistant to primary pharmacological and/or behavior therapy options. Results from 26 severe, treatment-resistant OCD patients treated with DBS at four collaborating centers, three in the US, and one in Europe are summarized in great detail in pages 12-22 of the provided/attached "Reclaim Summary of Safety and Probable Benefit."

Conditions

Obsessive-Compulsive Disorder (OCD)

Keywords

Treatment-Resistant; Anxiety

Outcome Measures

Primary Outcomes (1)

• Efficacy as indicated by a decrease in obsessive compulsive symptoms as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  The Y-BOCS scale is used to determine severity of OCD and to monitor improvement during treatment. This scale, which measures obsessions separately from compulsions, specifically measures the severity of symptoms of obsessive-compulsive disorder without being biased towards the type of content of obsessions or compulsions present. The Y-BOCS scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total possible score range from 0 to 40. The scale includes questions about the amount of time the patient spends on obsessions, how much impairment or distress they experience, and how much resistance and control they have over these thoughts. The same types of questions are asked about compulsions (e.g., time spent, interference, etc.) as well. The results can be interpreted based on the total score: 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; 32-40 is extreme.

  1 year

Secondary Outcomes (1)

• Safety as indicated by the number of Adverse Events

  1 year

Study Arms (1)

Reclaim™ DBS Therapy

EXPERIMENTAL

Procedure: The DBS lead is stereotactically introduced into the target in the brain and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region. This is performed by a neurosurgeon skilled in this technique, as the same procedure is routinely performed in patients with other diseases (using other brain targets).

Device: Reclaim™ DBS Therapy

Interventions

Reclaim™ DBS Therapy DEVICE

DBS is indicated for bilateral stimulation of the ventral anterior limb of the internal capsule as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs). Medtronic received humanitarian device exemption (HDE) approval for Reclaim DBS Therapy for the management of OCD on February 19, 2009.

Reclaim™ DBS Therapy

Eligibility Criteria

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

You may qualify if:

• Have a diagnosis of OCD with a documented duration of at least 5 years
• Have OCD rated as severe or extreme illness
• Have failed to improve following treatment with at least 3 selective serotonin reuptake inhibitors (SSRIs) and clomipramine
• Do not have hoarding as their primary subclassification
• Have completed or tried to complete Exposure and Response Prevention Therapy (ERP)
• Have no serious psychiatric disorder in addition to OCD (e.g. comorbid personality disorder) or current substance abuse issues
• Meet established criteria for implantation of a deep brain stimulation system
• Are 18 years old or older
• Have not had a previous surgery to destroy the region of the brain that will be the target of stimulation
• Are not pregnant
• Have no other neurological disorders, including dementia
• Do not have a bleeding disorder or are not taking blood thinners
• Are capable of giving informed consent

You may not qualify if:

• Patients who are unable to properly operate the neurostimulator
• Patients who will be exposed to diathermy

Sponsors & Collaborators

• Northwell Health: lead
• Medtronic: collaborator

Study Sites (1)

Zucker Hillside Hospital

Queens, New York, 11004, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Albert J Fenoy, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Gonzalez

CONTACT

7184704152; sgonzalez30@northwell.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: Director, Functional Neurosurgery

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: May 16, 2016
• Study Start: July 6, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: October 29, 2025

Record last verified: 2025-10

Locations

US (1)