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RECRUITING
NCT02773082
NA

DBS for Obsessive-Compulsive Disorder

Sponsor: Northwell Health

View on ClinicalTrials.gov

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."

Official title: Reclaim™ Deep Brain Stimulation (DBS) Therapy for Obsessive-Compulsive Disorder (OCD)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-07-06

Completion Date

2030-01-01

Last Updated

2025-10-29

Healthy Volunteers

No

Interventions

DEVICE

Reclaim™ DBS Therapy

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.

Locations (1)

Zucker Hillside Hospital

Queens, New York, United States