Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT02773082

DBS for Obsessive-Compulsive Disorder

Led by Northwell Health · Updated on 2025-10-29

50

Participants Needed

1

Research Sites

286 weeks

Total Duration

On this page

Sponsors

N

Northwell Health

Lead Sponsor

M

Medtronic

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

DBS for Obsessive-Compulsive Disorder

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of OCD lasting at least 5 years
  • OCD rated as severe or extreme illness
  • Failure to improve after treatment with at least 3 SSRIs and clomipramine
  • No primary hoarding subtype
  • Completed or attempted Exposure and Response Prevention Therapy (ERP)
  • No serious psychiatric disorders other than OCD or current substance abuse
  • Meet criteria for DBS system implantation
  • Age 18 years or older
  • No prior brain surgery targeting the stimulation area
  • Not pregnant
  • No other neurological disorders, including dementia
  • No bleeding disorders or use of blood thinners
  • Able to give informed consent
Not Eligible

You will not qualify if you...

  • Unable to operate the neurostimulator properly
  • Exposure to diathermy planned or expected

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zucker Hillside Hospital

Queens, New York, United States, 11004

Actively Recruiting

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Research Team

S

Samantha Gonzalez

CONTACT

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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