Refining the Target for Deep Brain Stimulation (DBS) in Severe, Treatment Refractory Obsessive Compulsive Disorder (OCD)

November 8, 2013 updated by: Universitaire Ziekenhuizen KU Leuven

In select, therapy resistent patients with Obsessive Compulsive Disorder (OCD) Deep Brain Stimulation (DBS) has been used as a treatment. DBS is a therapy modality in which electrodes are implanted within specific sub-structures of the brain in order to modulate the activity in targeted neural circuits associated with different neurological disorders. The results of this novel approach to psychiatric disorders have been optimistic. This study aims to investigate wether or not the distance to target location has an influence on the outcome.

In order to deliver DBS, leads containing four electrodes are implanted into the brain target in the ventral capsule/ventral striatum (VC/VS). After an optimization period, patients enter a triple blind randomised two fazed crossover design of two periods of three months. In both crossover branches, patients, evaluating psychiatrist and psychologist are blinded for the stimulation conditions. These conditions are stimulation ON (at optimal parameters) and stimulation OFF. Stimulation parameters are constant during the entire period. During the second crossover branch, stimulation conditions are reversed for all patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD (300.3).
  • Failure of documented trials of pharmacotherapy, following an appropriate treatment algorithm for OCD.
  • Failure of documented trial of cognitive and behavioural therapy
  • Duration of illness: min. 5 year
  • Y-BOCS at least 30/40.
  • Age: 20-65 year

Exclusion Criteria:

  • DSM-IV diagnosis on axis 2 of severe personality disorder in cluster A or B, especially in the case of heightened risk for acting-out behavior.
  • DSM-IV diagnosis on axis 3 of organic brain pathology or significant abnormalities on MRI.
  • Present or past history of psychotic symptoms.
  • Present substance abuse, or instable remission of substance abuses (i.e. no substance abuse during the last 12 months).
  • Any disorder affecting cognitive functioning, other than motor tics and Gilles de la Tourette's Syndrome
  • Mental retardation. A minimum threshold of cognitive skills is needed for adequate reporting on questionnaires and evaluation, and for technical handling of the instruments in a later faze.
  • The patient must be juridical free.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VC/VS stimulation ON followed by OFF
triple blind, randomised, two periods of three months
Device: VC/VS stimulation
Other Names:
  • Neurostimulator: Kinetra (Medtronic)
  • Electrode: 3387 (Medtronic)
Experimental: VC/VS stimulation OFF followed by ON
triple blind, randomised, two periods of three months
Device: VC/VS stimulation
Other Names:
  • Neurostimulator: Kinetra (Medtronic)
  • Electrode: 3387 (Medtronic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame: up to 12 months
up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impression (CGI)
Time Frame: up to 12 months
up to 12 months
Global assessment of functioning (GAF)
Time Frame: up to 12 months
up to 12 months
Hamilton scale for anxiety
Time Frame: up to 12 months
up to 12 months
Beck depression inventory
Time Frame: up to 12 months
up to 12 months
Inventory of Depressive Symptoms (IDS)
Time Frame: up to 12 months
up to 12 months
Patient Global Impression (PGI).
Time Frame: up to 12 months
up to 12 months
Symptom Checklist (SCL-90)
Time Frame: up to 12 months
up to 12 months
Quality of Life and Satisfaction Questionnaire (Q-Les-Q)
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

November 8, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Estimate)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 8, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s50927

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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