Evaluating Unilateral Deep Brain Stimulation in Patients With Obsessive Compulsive Disorder

Catholic University (KU) of Leuven

Status: Completed

Conditions: Obsessive-Compulsive Disorder

Treatments: Device: Electrical stimulation of the BNST

Study type: Interventional

Funder types: Other

Identifiers

NCT03894397

S62175

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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9 participants in 4 patient groups, including a placebo group

Stimulation of left BNST

Experimental group

Treatment:

Device: Electrical stimulation of the BNST

Stimulation of right BNST

Experimental group

Treatment:

Device: Electrical stimulation of the BNST

Stimulation of bilateral BNST

Experimental group

Treatment:

Device: Electrical stimulation of the BNST

Stimulation OFF

Placebo Comparator group

Treatment:

Device: Electrical stimulation of the BNST