Deep Brain Stimulation for Obsessive-compulsive Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deep brain stimulation.
- Who it may be relevant to
- Registry conditions: Obsessive-Compulsive Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Deep Brain Stimulation for the Treatment of Severe Obsessive-compulsive Disorder
Overview
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.
Interventions
- Device Deep brain stimulation
Stimulation through a device implanted bilaterally into deep brain structures.
Primary outcome measures
- Yale-Brown Obsessive Compulsive Scale, Y-BOCS [Time frame: From enrollment to the end of treatment after 6 months.]
Secondary outcome measures (5)
- Hamilton Anxiety Scale, HAS [Time frame: From enrollment to the end of treatment after 6 months.]
- Hamilton Depression scale, HAMD [Time frame: From enrollment to the end of treatment after 6 months.]
- Montgomery Asberg Depression Rating Scale, MADRS [Time frame: From enrollment to the end of treatment after 6 months.]
- Global Assessment of Functioning, GAF [Time frame: From enrollment to the end of treatment after 6 months.]
- Clinical Global Impression rating scale, CGI [Time frame: From enrollment to the end of treatment after 6 months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Umeå University — Umeå
Identifiers
NCT: NCT06628752 · 19-2018