Evaluating Unilateral Deep Brain Stimulation in Patients With Obsessive Compulsive Disorder

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.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical stimulation of the BNST

Device

Electrical stimulation of the BNST

Primary outcomes

Visual analogue scale (VAS) ratings of mood and anxiety/stress

Time frame: After 15 minutes of stimulation

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.

Secondary outcomes

VAS ratings of obsessive thoughts, urge to perform compulsive behavior, avoidance and global wellbeing

Time frame: After 15 minutes of stimulation

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.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

Evaluating Unilateral Deep Brain Stimulation (DBS) of the Bed Nucleus of the Stria Terminalis (BNST) in Patients With Obsessive Compulsive Disorder (OCD)

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Mar 28, 2019
Registry last updated: Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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