Unilateral Deep Brain Stimulation (DBS) of the Nucleus (Nucl.) Accumbens (Acc.) in Patients With Treatment Resistant Obsessive Compulsive Disorder (OCD)
The purpose of the study was to evaluate whether a unilateral Deep Brain Stimulation of the right Nucleus Accumbens could lead to a more than 35% reduction of symptoms in patients with a treatment resistant Obsessive Compulsive Disorder within two years.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Unilateral Deep Brain Stimulation of the Nucleus Accumbens in Patients With Treatment Resistant Obsessive Compulsive Disorder|
- Yale-Brown Obsessive Compulsive Scale [ Time Frame: Baseline (preoperative), 1week, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
- Beck Depression Inventory [ Time Frame: Baseline (preoperative), 1 week, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Study Completion Date:||February 2008|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Procedure: Deep Brain Stimulation
From the late ninety`s on, a few work groups published the case series of patients with treatment resistant OCD undergoing deep brain stimulation (DBS). This stereotactical method involves surgically implanted electrodes and previously has been used primarily for the treatment of Parkinson`s disease and tremor.
In almost all reported cases, a bilateral stimulation in the anterior limb of the internal capsule (ALIC was applied. However, the electrode designs between the groups varied and in some cases the stimulation area was extended to the adjacent ventral striatal regions including the nucleus accumbens (NAC).
Cortical-striate-thalami-cortical (CSTC) circuits are supported to be implicated in the pathogenesis underlying OCD caused by a failure of inhibition of the ventral striatum. Together with other structures the nucleus accumbens forms the ventral striatum. Because of the predominant role of the NAC to exert modulatory effects within these circuits we considered it to provide a promising target location for DBS.
Moreover the NAC ventrally borders with the anterior limb of the internal capsule and the subventricular lateral fundus of the nucleus accumbens is even permeated in rostral sections by numerous internal capsule fiber bundles. It was therefore to be expected that the electrode trajectories and stimulation target selected by us additionally would have an effect on the fibre systems of the internal capsule.
The NAC had been introduced as primary target for DBS in treatment resistant OCD by our group. Pilot series showed that the right stimulation of the NAC yielded the best results, whereas bilateral stimulation showed no additional benefit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724490
|Department of Psychiatry, University of Cologne|
|Cologne, NRW, Germany, 50924|
|Principal Investigator:||Joachim Klosterkötter, MD||Department of Psychiatry, Head of Department, University of Cologne|