Deep Brain Stimulation for Obsessive-compulsive Disorder

Not Applicable

Recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Device: Deep brain stimulation

• Registration Number: NCT06628752
• Lead Sponsor: Umeå University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-11
• Status Verified: 2024-10
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-08
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active stimulation	Deep brain stimulation	Deep brain stimulation - active stimulation
Sham stimulation	Deep brain stimulation	Deep brain stimulation - no stimulation

Primary Outcome Measures

Name	Time	Method
Yale-Brown Obsessive Compulsive Scale, Y-BOCS	From enrollment to the end of treatment after 6 months.	Validated psychometric scale that measures symptoms of OCD.

Secondary Outcome Measures

Name	Time	Method
Hamilton Anxiety Scale, HAS	From enrollment to the end of treatment after 6 months.	Validated psychometric scale that measures symptoms of anxiety.
Hamilton Depression scale, HAMD	From enrollment to the end of treatment after 6 months.	Validated psychometric scale that measures symptoms of depression.
Montgomery Asberg Depression Rating Scale, MADRS	From enrollment to the end of treatment after 6 months.	Validated psychometric scale that measures symptoms of depression.
Global Assessment of Functioning, GAF	From enrollment to the end of treatment after 6 months.	Scale that measures level of functioning.
Clinical Global Impression rating scale, CGI	From enrollment to the end of treatment after 6 months.	Scale that measures symptom improvement.

Trial Locations

Locations (1)

Umeå University; 🇸🇪 Umeå, Västerbotten, Sweden