Evaluating Unilateral Deep Brain Stimulation in Patients With Obsessive Compulsive Disorder
Evaluating Unilateral Deep Brain Stimulation (DBS) of the Bed Nucleus of the Stria Terminalis (BNST) in Patients With Obsessive Compulsive Disorder (OCD)
Lead Sponsor: KU Leuven
The investigators previously showed that deep brain stimulation (DBS) in the bed nucleus of the stria terminalis (BNST) reduces symptoms in patients with severe obsessive-compulsive disorder (OCD). Although most patients now receive bilateral stimulation, multiple studies suggest that stimulation of the left BNST might be equally effective.
In this study, the investigators will evaluate the effect of unilateral stimulation in OCD patients who currently receive bilateral BNST stimulation to treat their symptoms. We hypothesize that unilateral stimulation of the left BNST will reduce anxious and depressive symptoms, compared to no stimulation.
The study entails a double-blinded, randomized cross-over design during which every patient undergoes four stimulation conditions: stimulation of the left, right or bilateral BNST, or no stimulation. During every condition, which takes about fifteen minutes, the patient is exposed to an individually determined stimulus that normally elicits OCD-related symptoms. The patients are then asked to fill out a short questionnaire to evaluate the severity of their symptoms during the four conditions. At the end of the cross-over phase, the stimulation parameters of each patient are restored.
|Start Date||March 26, 2019|
|Completion Date||September 1, 2019|
|Primary Completion Date||September 1, 2019|
Intervention Type: Device
Intervention Name: Electrical stimulation of the BNST
Description: Electrical stimulation of the BNST
Inclusion criteria: - Clinical diagnosis of obsessive-compulsive disorder - Implanted with DBS system in the bilateral BST (or max. 4mm removed from the BST outline) - At least three months of chronic BST stimulation - Compulsive behavior can be provoked within a clinical setting Exclusion criteria: - Personality changes evoked by chronic DBS - Cognitive impairment
- Clinical diagnosis of obsessive-compulsive disorder
- Implanted with DBS system in the bilateral BST (or max. 4mm removed from the BST outline)
- At least three months of chronic BST stimulation
- Compulsive behavior can be provoked within a clinical setting
- Personality changes evoked by chronic DBS
- Cognitive impairment
Minimum Age: N/A
Maximum Age: N/A
Healthy Volunteers: No
Type: Principal Investigator
Investigator Affiliation: KU Leuven
Investigator Full Name: Kelly Luyck
Investigator Title: PhD
|Has Expanded Access||No|
|Number Of Arms||4|
Label: Stimulation of left BNST
Label: Stimulation of right BNST
Label: Stimulation of bilateral BNST
Label: Stimulation OFF
Type: Placebo Comparator
|Study Design Info||
Intervention Model: Crossover Assignment
Intervention Model Description: We will evaluate the effect of unilateral and bilateral stimulation of the BNST. Four conditions will be evaluated: left BNST stimulation, right BNST stimulation, bilateral BNST stimulation or no stimulation (OFF). Note that the order of these conditions is stratified beforehand (www.random.org). Each condition takes around 15 minutes.
Primary Purpose: Treatment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Both the patient and the psychiatrist are blinded during the cross-over phase, until the end of the study. The investigator who will evaluate behavior from the videorecordings, will also be blinded. Unblinded are: the principal investigator (who has access to all data) and the technical staff in charge of stimulation settings.