NCT06628752 Deep Brain Stimulation for Obsessive-compulsive Disorder
| NCT ID | NCT06628752 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Umeå University |
| Condition | Obsessive-Compulsive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2018-09-11 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 26 participants in total. It began in 2018-09-11 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Patric Blomstedt, Professor
STUDY CHAIR
Umeå University
Frequently Asked Questions
Who can join the NCT06628752 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obsessive-Compulsive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06628752 currently recruiting?
Yes, NCT06628752 is actively recruiting participants. Contact the research team at viktoria.johansson@umu.se for enrollment information.
Where is the NCT06628752 trial being conducted?
This trial is being conducted at Umeå, Sweden.
Who is sponsoring the NCT06628752 clinical trial?
NCT06628752 is sponsored by Umeå University. The principal investigator is Patric Blomstedt, Professor at Umeå University. The trial plans to enroll 26 participants.