DIPS (Dystonia Image-based Programming of Stimulation: a prospective, randomized, double-blind crossover trial).
Florian Lange, Jonas Roothans, Tim Wichmann...
https://pubmed.ncbi.nlm.nih.gov/34924027Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05097001
Dystonia Image-based Programming of Stimulation: A Prospective, Randomized, Double-blind Crossover Trial
Led by Wuerzburg University Hospital · Updated on 2025-01-28
80
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
W
Wuerzburg University Hospital
Lead Sponsor
B
BMBF (Bundes Ministerium fuer Bildung und Forschung)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the feasibility of using image-guided programming for pallidal deep brain stimulation (DBS) in treating dystonia, a group of movement disorders characterized by involuntary muscle contractions causing abnormal postures and movements. Dystonia significantly impacts motor function and quality of life, with current DBS therapy showing variable outcomes and up to 25% of patients not responding well. The study will compare a computer model predicting optimal stimulation settings against conventional clinical programming in a randomized, double-blind, crossover design. Participants will undergo DBS programming adjustments based either on a computer-guided assessment or on clinical evaluation. The study involves two programming approaches: computer-assisted and clinically-guided, with each participant receiving both in a randomized order. This design allows comparison of the effectiveness of model-predicted settings versus traditional clinical programming over defined follow-up periods. During the trial, participants will be monitored over several weeks, with dystonia severity assessed at 8 weeks to determine treatment success. Additional assessments include quality of life surveys at 4 and 8 weeks, energy consumption calculations, and time needed for programming at baseline. The study aims to measure improvements in dystonia symptoms, quality of life, and programming efficiency while monitoring safety and participant well-being throughout the process.
CONDITIONS
Brief Title
Dystonia Image-based Programming of Stimulation: A Prospective, Randomized, Double-blind Crossover Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Chronic deep brain stimulation implanted in the internal globus pallidus for isolated dystonia for more than 1 year
- Stable deep brain stimulation settings and dystonia medication for more than 3 months
- Ability to understand the study and provide signed informed consent
You will not qualify if you...
- Presence of significant comorbidities that could affect study outcomes, especially palliative disease or severe neurological or psychiatric disorders
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Each programming period lasts 8 weeks
Participants receive deep brain stimulation (DBS) programming based on either computer-guided or clinically-guided assessments in a randomized, crossover design.
Baseline visit and follow-up visits at 4 weeks and 8 weeks for each programming period
Trial Site Locations
Total: 1 location
1
Department of Neurology, University Hospital Würzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
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Research Team
M
Martin Reich, Dr.
F
Florian Lange, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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