Deep brain stimulation for severe obsessive-compulsive disorder
Deep Brain Stimulation for the Treatment of Severe Obsessive-compulsive Disorder
This study is testing if deep brain stimulation can help people with severe obsessive-compulsive disorder who haven't found relief with other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Umeå University Academic / other |
| Locations | 1 site (Umeå, Västerbotten County) |
| Trial ID | NCT06628752 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of deep brain stimulation (DBS) in patients with severe and treatment-resistant obsessive-compulsive disorder (OCD). Participants will be randomly assigned to receive either active or sham DBS targeting the bed nucleus of stria terminalis (BNST) for six months. The primary outcome is the reduction of OCD symptoms, while secondary outcomes include changes in anxiety, depressive symptoms, and daily functioning. Following the initial phase, all participants will receive continuous DBS and will be monitored with yearly follow-ups using validated psychometric scales.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with severe OCD who have not benefited from previous treatments, including cognitive behavioral therapy and multiple medications.
Not a fit: Patients with intellectual disabilities or those unable to understand the treatment consequences will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce OCD symptoms in patients who have not responded to traditional therapies.
How similar studies have performed: Other studies have shown promising results with deep brain stimulation for OCD, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Umeå, Västerbotten County
- Umeå University — Umeå, Västerbotten County, Sweden (Recruiting)
Study contacts
- Study coordinator: Viktoria Johansson, PhD
- Email: viktoria.johansson@umu.se
- Phone: +46-90-786 50 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.