NCT01985815

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
Last Updated

November 15, 2013

Status Verified

June 1, 2013

Enrollment Period

1.9 years

First QC Date

October 22, 2013

Last Update Submit

November 8, 2013

Conditions

Obsessive-Compulsive Disorder

Keywords

obsessive-compulsive disorderDeep Brain StimulationPsychosurgery

Outcome Measures

Primary Outcomes (1)

  • Yale Brown Obsessive Compulsive Scale (Y-BOCS)

    up to 12 months

Secondary Outcomes (8)

  • Clinical Global Impression (CGI)

    up to 12 months

  • Global assessment of functioning (GAF)

    up to 12 months

  • Hamilton scale for anxiety

    up to 12 months

  • Beck depression inventory

    up to 12 months

  • Inventory of Depressive Symptoms (IDS)

    up to 12 months

  • +3 more secondary outcomes

Study Arms (2)

VC/VS stimulation ON followed by OFF

EXPERIMENTAL

triple blind, randomised, two periods of three months

Device: VC/VS stimulation

VC/VS stimulation OFF followed by ON

EXPERIMENTAL

triple blind, randomised, two periods of three months

Device: VC/VS stimulation

Interventions

VC/VS stimulationDEVICE
Also known as: Neurostimulator: Kinetra (Medtronic), Electrode: 3387 (Medtronic)
VC/VS stimulation OFF followed by ONVC/VS stimulation ON followed by OFF

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

November 15, 2013

Study Start

March 1, 2008

Primary Completion

February 1, 2010

Last Updated

November 15, 2013

Record last verified: 2013-06

Locations

BE(1)