About this trial
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 criteria
Qualifiers
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
Disqualifiers
Patients who are unable to properly operate the neurostimulator
Patients who will be exposed to diathermy
Trial design
Treatments tested in this trial
- Reclaim™ DBS Therapy
Treatment groups
Sponsors and collaborators
Northwell Health
Lead sponsor
Medtronic
Collaborator