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.

Study Overview

• Status: Completed
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Procedure: Deep Brain Stimulation

Detailed Description

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
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Cologne, NRW, Germany, 50924
      • Department of Psychiatry, University of Cologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Yale-Brown Obsessive Compulsive Scale	Baseline (preoperative), 1week, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Beck Depression Inventory	Baseline (preoperative), 1 week, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Collaborators and Investigators

• Sponsor: University of Cologne
• Investigators: Principal Investigator: Joachim Klosterkötter, MD, Department of Psychiatry, Head of Department, University of Cologne

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 28, 2008
• First Posted (Estimate): July 29, 2008

Study Record Updates

• Last Update Posted (Estimate): July 29, 2008
• Last Update Submitted That Met QC Criteria: July 28, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation; Obsessive Compulsive Disorder; Nucleus Accumbens
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Anxiety Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: Ocdbs-Psy-120304