Ireland
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Recruiting Not applicable

Deep Brain Stimulation for Obsessive-compulsive Disorder

NCT06628752 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2018-09-11
Last updated
2024-10-17

Condition(s) studied

Obsessive-Compulsive Disorder

Investigational drug(s) / intervention(s)

Deep brain stimulation

Deep brain stimulation: Stimulation through a device implanted bilaterally into deep brain structures.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Umeå University Umeå Västerbotten County Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06628752 on ClinicalTrials.gov ↗ ← All trials in Sweden