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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Zucker Hillside Hospital
RECRUITING
Queens
Contact Information
Primary
Jenna Schugart
jschugart@northwell.edu
7184708446
Time Frame
Start Date: 2024-07-06
Estimated Completion Date: 2030-01-01
Participants
Target number of participants: 50
Treatments
Experimental: Reclaim™ DBS Therapy
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).
Sponsors
Collaborators: Medtronic
Leads: Northwell Health

This content was sourced from clinicaltrials.gov