Deep Brain Stimulation for Obsessive-compulsive Disorder

Deep Brain Stimulation for the Treatment of Severe Obsessive-compulsive Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: Deep brain stimulation

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Viktoria Johansson, PhD; Phone Number: +46-90-786 50 00; Email: viktoria.johansson@umu.se
• Study Contact Backup: Name: Matilda Naesstrom, PhD; Phone Number: +46-90-786 50 00; Email: matilda.naesstrom@umu.se

Study Locations

• Sweden
  • Västerbotten
    • Umeå, Västerbotten, Sweden, 90187
      • Recruiting
      • Umeå University
      • Contact: Viktoria Johansson, PhD; Phone Number: +46-90-786 50 00; Email: viktoria.johansson@umu.se
      • Contact: Matilda Naesstrom, PhD; Phone Number: +46-90-786 50 00; Email: matilda.naesstrom@umu.se
      • Contact: Patric Blomstedt, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active stimulation; Deep brain stimulation - active stimulation	Device: Deep brain stimulation; Stimulation through a device implanted bilaterally into deep brain structures.
Sham Comparator: Sham stimulation; Deep brain stimulation - no stimulation	Device: Deep brain stimulation; Stimulation through a device implanted bilaterally into deep brain structures.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Region Västerbotten
• Investigators: Study Chair: Patric Blomstedt, Professor, Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2018
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Deep Brain Stimulation; Obsessive-Compulsive Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 19-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not share IPD until the study is finished and results are published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No