RecruitingNot ApplicableNCT02773082

DBS for Obsessive-Compulsive Disorder

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


Sponsor

Northwell Health

Enrollment

50 participants

Start Date

Jul 6, 2024

Study Type

INTERVENTIONAL

Conditions

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."


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing deep brain stimulation (DBS) — a procedure that implants a small device to deliver electrical signals to a specific area of the brain — as a treatment for people with severe, treatment-resistant obsessive-compulsive disorder (OCD) who have not improved with multiple medications and therapy. **You may be eligible if...** - You have been diagnosed with OCD for at least 5 years - Your OCD is rated as severe or extreme - You have tried and failed at least 3 different SSRI antidepressants and a medication called clomipramine - You have attempted or completed exposure and response prevention therapy (ERP) - Hoarding is not your primary OCD symptom - You are 18 years or older and not pregnant - You have had no prior brain surgery targeting the same area **You may NOT be eligible if...** - You have another serious psychiatric disorder in addition to OCD (e.g., a personality disorder) or active substance abuse - You have other neurological conditions - You do not meet the medical criteria for brain implant surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEReclaim™ 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

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NCT02773082


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