Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Image-guided programming for deep brain stimulation in dystonia

Official title: Dystonia Image-based Programming of Stimulation: A Prospective, Randomized, Double-blind Crossover Trial

Run by Wuerzburg University Hospital · NCT05097001 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorWuerzburg University Hospital
Academic / other
Locations1 site (Würzburg, Bavaria)
StatusRecruiting
StartedNovember 1, 2021
Main results expectedSeptember 2025
Study endsDecember 2025
Registry record updatedJanuary 28, 2025
Trial IDNCT05097001 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals with chronic deep brain stimulation for isolated dystonia who have stable medication and stimulation settings.

Probably not a fit

Patients with significant comorbidities that could interfere with study outcomes may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.