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)

Sponsors

Lead Sponsor: KU Leuven

Source KU Leuven
Brief Summary

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.

Overall Status Completed
Start Date March 26, 2019
Completion Date September 1, 2019
Primary Completion Date September 1, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Visual analogue scale (VAS) ratings of mood and anxiety/stress After 15 minutes of stimulation
Secondary Outcome
Measure Time Frame
VAS ratings of obsessive thoughts, urge to perform compulsive behavior, avoidance and global wellbeing After 15 minutes of stimulation
Enrollment 9
Condition
Intervention

Intervention Type: Device

Intervention Name: Electrical stimulation of the BNST

Description: Electrical stimulation of the BNST

Eligibility

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: Catholic University Leuven
Location Countries

Belgium

Verification Date

September 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: KU Leuven

Investigator Full Name: Kelly Luyck

Investigator Title: PhD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Stimulation of left BNST

Type: Experimental

Label: Stimulation of right BNST

Type: Experimental

Label: Stimulation of bilateral BNST

Type: Experimental

Label: Stimulation OFF

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

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.

Source: ClinicalTrials.gov