DBS for Obsessive-Compulsive Disorder

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."

Conditions

Obsessive-Compulsive Disorder (OCD)

Study Overview

Study Details

Study overview

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."

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

DBS for Obsessive-Compulsive Disorder

Condition
Obsessive-Compulsive Disorder (OCD)
Intervention / Treatment

-

Contacts and Locations

Queens

Zucker Hillside Hospital, Queens, New York, United States, 11004

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwell Health,

Albert J Fenoy, MD, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

2030-01-01