Deep Brain Stimulation for Obsessive-compulsive Disorder

Umeå University

Status: Enrolling

Conditions: Obsessive-Compulsive Disorder

Treatments: Device: Deep brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06628752

19-2018

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the treatment method of deep brain stimulation (DBS) in patients diagnosed with severe and treatment-resistant obsessive-compulsive disorder (OCD). DBS will be administered into the brain area of the bed nucleus of stria terminalis (BNST).

The main research questions are:

• Does active DBS in BNST reduce OCD symptoms (primary outcome)?
• Does active DBS in BNST reduce anxiety or depressive symptoms and improve the level of daily function?

The participants will be randomized to active or sham DBS in the BNST for six months and we will measure the outcomes before DBS surgery, and six months post-surgery. After the randomization phase, the participants will enter an open-label phase and receive continuous DBS in BNST. Yearly follow-ups will be conducted. The outcomes will be measured through interviews using validated psychometric scales.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• OCD diagnosed according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
• The patients should have received at least 16 sessions of cognitive behavioral therapy, tried three different serotonergic antidepressants in adequate doses for three months, and one serotonergic antidepressant in combination with a neuroleptic drug.
• Severe OCD symptoms: YBOCS ≥ 25 points.
• Substantial incapacity because of his/her symptoms.
• Duration of symptoms: 5 years minimum.
• Understand the consequences of participation in the study and give informed written consent.

Exclusion criteria

• Not being able to understand the consequences of the treatment.
• Diagnosed with intellectual disability according to DSM-IV.
• Not meeting the requirements for the neurosurgery procedure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Active stimulation

Active Comparator group

Description:

Deep brain stimulation - active stimulation

Treatment:

Device: Deep brain stimulation

Sham stimulation

Sham Comparator group

Description:

Deep brain stimulation - no stimulation

Treatment:

Device: Deep brain stimulation