Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VC/VS stimulation ON followed by OFF | Experimental | triple blind, randomised, two periods of three months |
|
| VC/VS stimulation OFF followed by ON | Experimental | triple blind, randomised, two periods of three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VC/VS stimulation | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale (Y-BOCS) | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression (CGI) | up to 12 months | |
| Global assessment of functioning (GAF) | up to 12 months | |
| Hamilton scale for anxiety |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
Not provided
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 12 months |
| Beck depression inventory | up to 12 months |
| Inventory of Depressive Symptoms (IDS) | up to 12 months |
| Patient Global Impression (PGI). | up to 12 months |
| Symptom Checklist (SCL-90) | up to 12 months |
| Quality of Life and Satisfaction Questionnaire (Q-Les-Q) | up to 12 months |