Recruiting

DBS

Sponsor:

Northwell Health

Code:

NCT02773082

Conditions

Obsessive-Compulsive Disorder (OCD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Reclaim™ DBS Therapy

Study Details

Brief 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."

Conditions

Obsessive-Compulsive Disorder (OCD)

Study ID

NCT02773082

Start date

Jul 6, 2024

Status verified date

Oct, 2025

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who are unable to properly operate the neurostimulator
  • Patients who will be exposed to diathermy

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

Reclaim™ 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.

Primary outcome measure

  • Efficacy as indicated by a decrease in obsessive compulsive symptoms as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Samantha Gonzalez

7184704152sgonzalez30@northwell.edu

Locations

Zucker Hillside Hospital

Recruiting

Queens, New York, United States, 11004

Contacts

Jenna Schugart

7184708446jschugart@northwell.edu

Principal Investigator:

Albert J Fenoy, MD

More Information

Sponsor

Northwell Health

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Keywords

  • Treatment-Resistant
  • Anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2025-10-29.