RECRUITING

DBS for Obsessive-Compulsive Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2024-07-06
Study Completion:2030-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02773082

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * have a diagnosis of OCD with a documented duration of at least 5 years;
  2. * have OCD rated as severe or extreme illness;
  3. * have comorbid depression and anxiety;
  4. * have failed to improve following treatment with at least 3 selective serotonin reuptake inhibitors (SSRIs)
  5. * have completed or tried to complete Cognitive Behavior Therapy (CBT);
  6. * have no serious psychiatric disorder in addition to OCD (e.g. comorbid personality disorder) or substance abuse issues;
  7. * meet established criteria for implantation of a deep brain stimulation system; are 18 years old or older;
  1. * hoarding as their primary subclassification;
  2. * have had a previous surgery to destroy the region of the brain that will be the target of stimulation;
  3. * are pregnant;
  4. * have any neurological disorders, including dementia;
  5. * have a bleeding disorder or are not taking blood thinners;
  6. * require routine MRIs.

Contacts and Locations

Study Contact

Jenn Schugart
CONTACT
7184708446
jschugart@northwell.edu

Principal Investigator

Albert J Fenoy, MD
PRINCIPAL_INVESTIGATOR
Northwell Health

Study Locations (Sites)

Zucker Hillside Hospital
Queens, New York, 11004
United States

Collaborators and Investigators

Sponsor: Northwell Health

  • Albert J Fenoy, MD, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-06
Study Completion Date2030-01-01

Study Record Updates

Study Start Date2024-07-06
Study Completion Date2030-01-01

Terms related to this study

Keywords Provided by Researchers

  • Treatment-Resistant
  • Anxiety

Additional Relevant MeSH Terms

  • Obsessive-Compulsive Disorder (OCD)