Evaluating Unilateral Deep Brain Stimulation in Patients With Obsessive Compulsive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-26

Study Completion Date

2019-09-01

Brief Summary

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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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Detailed Description

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Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

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Stimulation of left BNST

Group Type EXPERIMENTAL

Electrical stimulation of the BNST

Intervention Type DEVICE

Electrical stimulation of the BNST

Stimulation of right BNST

Group Type EXPERIMENTAL

Electrical stimulation of the BNST

Intervention Type DEVICE

Electrical stimulation of the BNST

Stimulation of bilateral BNST

Group Type EXPERIMENTAL

Electrical stimulation of the BNST

Intervention Type DEVICE

Electrical stimulation of the BNST

Stimulation OFF

Group Type PLACEBO_COMPARATOR

Electrical stimulation of the BNST

Intervention Type DEVICE

Electrical stimulation of the BNST

Interventions

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Electrical stimulation of the BNST

Intervention Type DEVICE

Eligibility Criteria

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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