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)

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: Electrical stimulation of the BNST

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Catholic University Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stimulation of left BNST	Device: Electrical stimulation of the BNST; Electrical stimulation of the BNST
Experimental: Stimulation of right BNST	Device: Electrical stimulation of the BNST; Electrical stimulation of the BNST
Experimental: Stimulation of bilateral BNST	Device: Electrical stimulation of the BNST; Electrical stimulation of the BNST
Placebo Comparator: Stimulation OFF	Device: Electrical stimulation of the BNST; Electrical stimulation of the BNST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale (VAS) ratings of mood and anxiety/stress	For every question on the VAS, there will be a line of 10 centimeters as an outcome measure. The patient will place a mark on this line, in correspondence to their symptoms. The minimum is 0%, which corresponds to no symptoms at all. The maximum is 100% (marker at the end of the 10 centimeter line), and indicates the most severe symptoms. Every millimiter that the mark is removed from the left boundary of the line, is considered as 1%. Measurements of mood and anxiety/stress will be scored using 2 VAS scales. We will only look at sub score, not total scores. A higher score corresponds to more severe symptoms. By using a continuous line as an outcome rather than fixed numbers (1-2-3-...), our rating is far more sensitive to small deviations in how symptoms are experienced.	After 15 minutes of stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS ratings of obsessive thoughts, urge to perform compulsive behavior, avoidance and global wellbeing	For every question on the VAS, there will be a line of 10 centimeters as an outcome measure. The patient will place a mark on this line, in correspondence to their symptoms. The minimum is 0%, which corresponds to no symptoms at all. The maximum is 100% (marker at the end of the 10 centimeter line), and indicates the most severe symptoms. For global wellbeing, a higher score corresponds to better therapeutic effects. Every millimiter that the mark is removed from the left boundary of the line, is considered as 1%. Obsessive thoughts, urge to perform compulsions, avoidance and global wellbeing will be measured using four separate VAS scales. We will only look at sub score, not total scores. By using a continuous line as an outcome rather than fixed numbers (1-2-3-...), our rating is far more sensitive to small deviations in how symptoms are experienced. For obsessive thoughts, urge to perform compulsions and avoidance, a higher score indicates more severe symptoms.	After 15 minutes of stimulation

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2019
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Anxiety; Mood; (Unilateral) Deep brain stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: S62175

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes