Deep Brain Stimulation in Severe 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

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2019-01-31

Brief Summary

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Deep brain stimulation is an established treatment for movement disorders. New indications for deep brain stimulation are under investigation, among them severe and treatment-resistant obsessive-compulsive disorder. Here, the investigators investigate clinical outcomes, safety and mechanism of action of DBS in the BNST in a series of 11 participants with severe therapy-refractory OCD.

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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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deep brain stimulation

Deep brain stimulation in the bed nucleus of stria terminalis

Group Type EXPERIMENTAL

Deep brain stimulation

Intervention Type DEVICE

Stereotactic functional neurosurgery was first developed in 1947 and is today an established treatment for movement disorders. The surgical procedure is initiated by mounting a stereotactic frame on the head of the patient and a magnetic resonance image (MRI) is performed. Using a computerized navigational system the target structure is identified on the MRI and a trajectory chosen. In the operating theatre a burrhole is made on each side of the midline for the implantation of two electrodes. The electrodes are about 1.3 mm in diameter with several contacts at their distal end. An extension cable is tunneled under the skin, connecting the electrodes with a neuropacemaker placed below the clavicle in a subcutaneous pocket. The hospitalization time after surgery is dependent on the time needed for programming of the device, but the patients can usually return home within 3-5 days.

Interventions

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Deep brain stimulation

Stereotactic functional neurosurgery was first developed in 1947 and is today an established treatment for movement disorders. The surgical procedure is initiated by mounting a stereotactic frame on the head of the patient and a magnetic resonance image (MRI) is performed. Using a computerized navigational system the target structure is identified on the MRI and a trajectory chosen. In the operating theatre a burrhole is made on each side of the midline for the implantation of two electrodes. The electrodes are about 1.3 mm in diameter with several contacts at their distal end. An extension cable is tunneled under the skin, connecting the electrodes with a neuropacemaker placed below the clavicle in a subcutaneous pocket. The hospitalization time after surgery is dependent on the time needed for programming of the device, but the patients can usually return home within 3-5 days.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Severe OCD according to the Diagnostic and Statistical Manual of Mental Disorders: DSM-IV
* YBOCS score of at least 25/40
* Disease duration of ≥5 years with persistent disabling symptoms despite adequate trials with at least 3 different serotonergic acting antidepressants, augmentation with antipsychotics, and CBT
* Only patients between 18 and 65 years of age who could understand and comply with instructions and provide their own written consent.