Back to results

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

Primary Purpose

Obsessive-Compulsive Disorder

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

VC/VS stimulation

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring obsessive-compulsive disorder, Deep Brain Stimulation, Psychosurgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

VC/VS stimulation ON followed by OFF

VC/VS stimulation OFF followed by ON

Arm Description

triple blind, randomised, two periods of three months

Outcomes

Primary Outcome Measures

Yale Brown Obsessive Compulsive Scale (Y-BOCS)

Secondary Outcome Measures

Clinical Global Impression (CGI)

Global assessment of functioning (GAF)

Hamilton scale for anxiety

Beck depression inventory

Inventory of Depressive Symptoms (IDS)

Patient Global Impression (PGI).

Symptom Checklist (SCL-90)

Quality of Life and Satisfaction Questionnaire (Q-Les-Q)

Full Information

NCT ID

NCT01985815

First Posted

October 22, 2013

Last Updated

November 8, 2013

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT01985815

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive-Compulsive Disorder

Keywords

obsessive-compulsive disorder, Deep Brain Stimulation, Psychosurgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VC/VS stimulation ON followed by OFF

Arm Type

Experimental

Arm Description

triple blind, randomised, two periods of three months

Arm Title

VC/VS stimulation OFF followed by ON

Arm Type

Experimental

Arm Description

triple blind, randomised, two periods of three months

Intervention Type

Device

Intervention Name(s)

VC/VS stimulation

Other Intervention Name(s)

Neurostimulator: Kinetra (Medtronic), Electrode: 3387 (Medtronic)

Primary Outcome Measure Information:

Title

Yale Brown Obsessive Compulsive Scale (Y-BOCS)

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

Clinical Global Impression (CGI)

Time Frame

up to 12 months

Title

Global assessment of functioning (GAF)

Time Frame

up to 12 months

Title

Hamilton scale for anxiety

Time Frame

up to 12 months

Title

Beck depression inventory

Time Frame

up to 12 months

Title

Inventory of Depressive Symptoms (IDS)

Time Frame

up to 12 months

Title

Patient Global Impression (PGI).

Time Frame

up to 12 months

Title

Symptom Checklist (SCL-90)

Time Frame

up to 12 months

Title

Quality of Life and Satisfaction Questionnaire (Q-Les-Q)

Time Frame

up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

UZ Leuven

City

Leuven

State/Province

Vlaams-Brabant

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs