Unilateral Deep Brain Stimulation (DBS) of the Nucleus (Nucl.) Accumbens (Acc.) in Patients With Treatment Resistant Obsessive Compulsive Disorder (OCD)

This study has been completed.
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00724490
First received: July 25, 2008
Last updated: July 28, 2008
Last verified: July 2008

July 25, 2008
July 28, 2008
February 2004
September 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00724490 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Unilateral Deep Brain Stimulation (DBS) of the Nucleus (Nucl.) Accumbens (Acc.) in Patients With Treatment Resistant Obsessive Compulsive Disorder (OCD)
Unilateral Deep Brain Stimulation of the Nucleus Accumbens in Patients With Treatment Resistant Obsessive Compulsive Disorder

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obsessive Compulsive Disorder
Procedure: Deep Brain Stimulation
Unilateral Deep Brain Stimulation in the right Nucleus Accumbens
Other Name: Model 3387 DBS Lead, Medtronic, Minneapolis, USA
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
February 2008
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Obsessive compulsive disorder (according to DSM IV-criteria) as the primary psychiatric diagnosis
  • severity level of OCD more than 25 on the Yale-Brown Obsessive Compulsive Scale
  • course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (treatment resistance)
  • treatment resistance: at least two serotonin reuptake inhibitors (SSRI´s), or one SSRI and clomipramine in sufficient dosages for at least 10 weeks, an augmentation trial with lithium, buspirone or a neuroleptic lasting at least 10 weeks, and complete cognitive-behavioral psychotherapy, including "exposure and response prevention" of a minimum of 20 sessions with a documented lack of efficiency
  • the ability to give written and informed consent

Exclusion Criteria:

  • co-morbid psychotic disorder according to DSM-IV criteria
  • suicidal tendencies in the last 6 months
  • history of cerebral trauma
  • clinically relevant internal or neurological disorder
  • substance misuse or dependence in the last six months
  • ineligibility to fulfill the neurosurgical and anesthesiological preconditions for the implantation of a DBS
  • pregnancy
  • lactation period
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00724490
Ocdbs-Psy-120304
No
Joachim Klosterkoetter, MD, Department of Psychiatry, University of Cologne, Germany
University of Cologne
Not Provided
Principal Investigator: Joachim Klosterkötter, MD Department of Psychiatry, Head of Department, University of Cologne
University of Cologne
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP