Unilateral Deep Brain Stimulation (DBS) of the Nucleus (Nucl.) Accumbens (Acc.) in Patients With Treatment Resistant Obsessive Compulsive Disorder (OCD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00724490|
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : July 29, 2008
|Condition or disease||Intervention/treatment||Phase|
|Obsessive Compulsive Disorder||Procedure: Deep Brain Stimulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Unilateral Deep Brain Stimulation of the Nucleus Accumbens in Patients With Treatment Resistant Obsessive Compulsive Disorder|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||February 2008|
Procedure: Deep Brain Stimulation
- Yale-Brown Obsessive Compulsive Scale [ Time Frame: Baseline (preoperative), 1week, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months ]
- Beck Depression Inventory [ Time Frame: Baseline (preoperative), 1 week, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|