DBS for Obsessive-Compulsive Disorder
Recruiting · NCT02773082 · Interventional (participants receive a specific treatment) · Lead sponsor: Northwell Health
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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."
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Zucker Hillside Hospital - Queens, New York, United States