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

RecruitingNAAges 18 Years - anyAllWuerzburg University Hospital
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In plain words

What the trial is, and whether it could suit you

The primary objective of this exploratory study is to prospectively evaluate the feasibility of image-guided programming of pallidal deep brain stimulation (DBS) for dystonia. The dystonias are a heterogeneous group of movement disorders that share the core clinical feature of abnormal involuntary muscle contractions in common. Pallidal DBS is an established therapy for severe cases with an average improvement in dystonia severity of 50-60%. However, outcomes are variable and difficult to predict, and clinical trials report up to 25% of Nonresponders. Variability in electrode placement and inappropriate stimulation settings may account for much of this variability in outcome. In addition, improvement in dystonia is delayed, often days to weeks after a change in DBS therapy, complicating programming. Our group recently developed a computer model to predict optimal individualized stimulat

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📋 Eligibility rules (as published)
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).
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What it tests

  • DBS programming
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Where

1 site
Department of Neurology, University Hospital Würzburg
Würzburg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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