A Study Comparing Computer-Guided and Clinical Programming of Deep Brain Stimulation for Dystonia

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.

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