Improving targeting precision in deep brain stimulation for OCD
Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD) in the Bed Nucleus of the Stria Terminalis (BNST): Improving Targeting Precision
This study is testing a new technique to see if it can improve the accuracy of deep brain stimulation for people with obsessive-compulsive disorder (OCD).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT02377375 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a micro-electrode assisted technique in improving targeting precision for deep brain stimulation (DBS) in patients with obsessive-compulsive disorder (OCD). Previous studies indicated deviations in targeting precision when DBS was applied to OCD patients compared to those with Parkinson's disease. The trial aims to determine if this new technique can enhance the accuracy of DBS at the bed nucleus of the stria terminalis (BNST) in OCD patients. Participants will be assessed based on their OCD diagnosis and treatment history.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20-65 with a diagnosis of OCD who have not responded to standard pharmacotherapy and cognitive behavioral therapy.
Not a fit: Patients with severe personality disorders, organic brain pathology, or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with OCD through improved targeting in DBS.
How similar studies have performed: While there have been studies on DBS for OCD, this specific approach using micro-electrode assistance is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD (300.3). * Failure of documented trials of pharmacotherapy, following an appropriate treatment algorithm for OCD. * Failure of documented trial of cognitive and behavioural therapy * Duration of illness: min. 5 year * Y-BOCS (Yale-Brown Obsessive Compulsive Scale) at least 30/40. * Age: 20-65 year Exclusion Criteria: * DSM-IV diagnosis on axis 2 of severe personality disorder in cluster A or B, especially in the case of heightened risk for acting-out behavior. * DSM-IV diagnosis on axis 3 of organic brain pathology or significant abnormalities on MRI. * Present or past history of psychotic symptoms. * Present substance abuse, or instable remission of substance abuses (i.e. no substance abuse during the last 12 months). * Any disorder affecting cognitive functioning, other than motor tics and Gilles de la Tourette's Syndrome * Mental retardation. A minimum threshold of cognitive skills is needed for adequate reporting on questionnaires and evaluation, and for technical handling of the instruments in a later faze.
Where this trial is running
Leuven, Vlaams-Brabant
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Bart Nuttin, MD, PHD — UZ Leuven
- Study coordinator: Bart Nuttin, MD, PHD
- Email: bart.nuttin@kuleuven.be
- Phone: 003216340859
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.