DBS for Obsessive-Compulsive Disorder

ConditionObsessive-Compulsive Disorder (OCD)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorNorthwell Health

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Reclaim™ DBS Therapy
Device
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.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Reclaim™ DBS TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Efficacy as indicated by a decrease in obsessive compulsive symptoms as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

The Y-BOCS scale is used to determine severity of OCD and to monitor improvement during treatment. This scale, which measures obsessions separately from compulsions, specifically measures the severity of symptoms of obsessive-compulsive disorder without being biased towards the type of content of obsessions or compulsions present. The Y-BOCS scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total possible score range from 0 to 40. The scale includes questions about the amount of time the patient spends on obsessions, how much impairment or distress they experience, and how much resistance and control they have over these thoughts. The same types of questions are asked about compulsions (e.g., time spent, interference, etc.) as well. The results can be interpreted based on the total score: 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; 32-40 is extreme.

Time frame

1 year

Secondary outcomes

Safety as indicated by the number of Adverse Events

Possible Adverse Events include: postoperative pain, stress, or discomfort lead repositioning stimulation not effective paresthesia dysarthria disequilibrium paresis intracranial hemorrhage DBS explantation erosion infection component malfunction (IPG, lead, extension) seizures subcutaneous hematoma electrical shocking or jolting headaches allergic reaction burr hole ring and cap failure electrode short circuit or open circuit attention or cognitive deficit, cramping diplopia dysphasia facial weakness neurostimulator changed from cycling mode to continuous mode insufficient oxygenation no connection at "0" electrode broken tunneling rod twelfth cranial nerve palsy

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

Medtronic

Collaborator

Source ClinicalTrials.gov

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