NCT02773082: DBS

DBS for Obsessive-Compulsive Disorder

Recruiting now NA Last updated 29 October 2025

What this trial tests

NA trial testing Reclaim™ DBS Therapy in Obsessive-Compulsive Disorder (OCD) in 50 participants. Currently enrolling.

Timeline

6 July 2024

Primary endpoint
1 January 2030

1 January 2030

Quick facts

Lead sponsor	Northwell Health
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	6 July 2024
Primary completion	1 January 2030
Estimated completion	1 January 2030
Sites	1 location across United States

Drugs / interventions tested

• Reclaim™ DBS Therapy

Conditions studied

• Obsessive-Compulsive Disorder (OCD) — all drugs for Obsessive-Compulsive Disorder (OCD) →

Sponsor

Northwell Health — full company profile →

Who can join

18 and older, any sex, with Obsessive-Compulsive Disorder (OCD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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."

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Obsessive-compulsive disorder.
   Stein DJ, Costa DLC, Lochner C, Miguel EC, et al · · 2019 · cited 495× · PMID 31371720 · DOI 10.1038/s41572-019-0102-3
2. Neuromodulation of OCD: A review of invasive and non-invasive methods.
   Kammen A, Cavaleri J, Lam J, Frank AC, et al · · 2022 · cited 18× · PMID 36016538 · DOI 10.3389/fneur.2022.909264
3. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
   Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991
4. Best practices for clinical trials of deep brain stimulation for neuropsychiatric indications.
   Tremblay-McGaw AG, Hamlat EJ, Becker NC, Astudillo Maya DA, et al · · 2025 · cited 1× · PMID 40309667 · DOI 10.3389/fnhum.2025.1572972