Image-guided programming for deep brain stimulation in dystonia
Dystonia Image-based Programming of Stimulation: A Prospective, Randomized, Double-blind Crossover Trial
This study is testing a new way to program deep brain stimulation for people with dystonia to see if it can improve their treatment results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wuerzburg University Hospital Academic / other |
| Locations | 1 site (Würzburg, Bavaria) |
| Trial ID | NCT05097001 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of using image-guided programming for pallidal deep brain stimulation (DBS) in patients with dystonia. Dystonia is characterized by involuntary muscle contractions, and while DBS is an established treatment, outcomes can be unpredictable, with a significant number of patients not responding to therapy. The researchers have developed a computer model to predict optimal stimulation settings based on data from previously treated patients, which may improve treatment outcomes. The study will involve a randomized, double-blind crossover design to assess the effectiveness of this new programming approach.
Who should consider this trial
Good fit: Ideal candidates include individuals with chronic deep brain stimulation for isolated dystonia who have stable medication and stimulation settings.
Not a fit: Patients with significant comorbidities that could interfere with study outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment for patients with dystonia, improving their quality of life.
How similar studies have performed: While there have been studies on DBS for dystonia, the specific image-guided programming approach being tested here is novel and has not been extensively evaluated in prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chronic deep brain stimulation (\> 1 year) in the internal globus pallidus in patients with isolated dystonia. * Deep brain stimulation settings and dystonia medication stable for \> 3 months. * Understanding about and consent to the study and signed informed consent form. Exclusion Criteria: * Relevant comorbidities that might interfere with study endpoints (esp. palliative disease and severe neurologic or psychiatric comorbidities).
Where this trial is running
Würzburg, Bavaria
- Department of Neurology, University Hospital Würzburg — Würzburg, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Martin Reich — Department of Neurology - University Hosiptal Würzburg
- Study coordinator: Martin Reich, Dr.
- Email: Reich_M1@ukw.de
- Phone: 0931-201-0
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.