Evaluating Two Types of Deep Brain Stimulation for Idiopathic Craniofacial Dystonia in Adults

What this Trial Is About

This research investigates the effects of deep brain stimulation DBS in patients with idiopathic craniofacial dystonia, a condition causing involuntary muscle contractions in the face. The study compares two DBS targets, the subthalamic nucleus STN and the globus pallidus internus GPi, to see if STN-DBS is not worse than GPi-DBS in improving motor symptoms one year after surgery. The trial is prospective, multicenter, randomized, and controlled, focusing on motor improvements measured by specific rating scales over time. Participants will be randomly assigned to receive DBS targeting either the STN or GPi under local and general anesthesia. The stimulator device will be activated three weeks after surgery to allow brain recovery. Those previously treated with medication will continue their treatment, while those without prior medication will avoid dystonia-related drugs. Assessments will occur at several intervals, including 90, 180, and 365 days postoperatively, evaluating motor function and other neurological and mental health aspects. Throughout the study, patients will undergo various clinical assessments including the Burke-Fahn-Marsden dystonia rating scale, blepharospasm disability index, cognitive tests, and mental health evaluations. Researchers will monitor device programming parameters and changes in motor symptoms over one year. The trial includes safety and functional outcome monitoring, with data collected at multiple time points to assess and compare the two treatments effects on idiopathic craniofacial dystonia.

Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN