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

Launched by WUERZBURG UNIVERSITY HOSPITAL · Oct 14, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to program deep brain stimulation (DBS) for people with dystonia, a condition that causes involuntary muscle contractions. The study aims to see if using a computer model to guide the programming of DBS can lead to better outcomes compared to the traditional methods used by doctors. This is important because while DBS can help many patients, some do not respond well to the treatment, and it can take time to see any improvements after changes are made.

To participate in this trial, you should be between the ages of 65 and 74 and have been receiving DBS for dystonia for over a year, with your treatment stable for the last three months. You’ll need to understand the study and provide your consent. If you join, you will be randomly assigned to receive either the new computer-guided programming or the standard programming, and your dystonia severity will be assessed to see which method works better. This trial is currently recruiting participants and aims to improve treatment options for individuals with this challenging condition.

Gender

ALL

Eligibility 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).