Actively Recruiting
Deep Brain Stimulation for Obsessive-compulsive Disorder
Led by Umeå University · Updated on 2024-10-17
26
Participants Needed
1
Research Sites
642 weeks
Total Duration
On this page
Sponsors
U
Umeå University
Lead Sponsor
R
Region Västerbotten
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Deep Brain Stimulation for Obsessive-compulsive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- OCD diagnosed according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
- At least 16 sessions of cognitive behavioral therapy received.
- Tried three different serotonergic antidepressants in adequate doses for three months.
- Tried one serotonergic antidepressant combined with a neuroleptic drug.
- Severe OCD symptoms with Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of 25 or higher.
- Substantial incapacity due to symptoms.
- Symptoms present for at least 5 years.
- Able to understand the consequences of participation and provide informed written consent.
You will not qualify if you...
- Unable to understand the consequences of the treatment.
- Diagnosed with intellectual disability according to DSM-IV.
- Not meeting the requirements for the neurosurgery procedure.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Umeå University
Umeå, Västerbotten County, Sweden, 90187
Actively Recruiting
Research Team
V
Viktoria Johansson, PhD
CONTACT
M
Matilda Naesstrom, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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