Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Zucker Hillside Hospital
Queens, New York, United States, 11004
Actively Recruiting
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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