Deep Brain Stimulation for Obsessive-compulsive Disorder

NCT06628752 | Recruiting

• 1 other identifier: 19-2018
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; Deep Brain Stimulation; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Hamilton Anxiety Scale, HAS

  From enrollment to the end of treatment after 6 months.

• Hamilton Depression scale, HAMD

  From enrollment to the end of treatment after 6 months.

• Montgomery Asberg Depression Rating Scale, MADRS

  From enrollment to the end of treatment after 6 months.

• Global Assessment of Functioning, GAF

  From enrollment to the end of treatment after 6 months.

• Clinical Global Impression rating scale, CGI

  From enrollment to the end of treatment after 6 months.

Study Arms (2)

Active stimulation

ACTIVE COMPARATOR

Deep brain stimulation - active stimulation

Device: Deep brain stimulation

Sham stimulation

SHAM COMPARATOR

Deep brain stimulation - no stimulation

Device: Deep brain stimulation

Interventions

Deep brain stimulation DEVICE

Stimulation through a device implanted bilaterally into deep brain structures.

Active stimulation; Sham stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead
• Region Västerbotten: collaborator

Study Sites (1)

Umeå University

Umeå, Västerbotten County, 90187, Sweden

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Patric Blomstedt, Professor

  Umeå University

  STUDY CHAIR

Central Study Contacts

Viktoria Johansson, PhD

CONTACT

+46-90-786 50 00; viktoria.johansson@umu.se

Matilda Naesstrom, PhD

CONTACT

+46-90-786 50 00; matilda.naesstrom@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant and the outcome assessor are blinded to whether the participant receives active or sham stimulation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial.

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: September 11, 2018
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)