Differences in Brain Network Mechanisms Between STN and GPi Deep Brain Stimulation in the Treatment of Craniocervical Dystonia
NCT Number: NCT06480188
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dystonia
Interventions: DEVICE: deep brain stimulation
Sponsor: Anhui Provincial Hospital
Collaborators: Beijing Pins Medical Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2026-03-31
Locations: The First Affiliated Hospital of Ustc, Hefei, Anhui, China

Summary:
Craniocervical dystonia, characterized by symptoms distributed in the craniofacial and/or cervical regions, is a type of focal or segmental dystonia and is the most common form of dystonia in adults. Deep brain stimulation (DBS) is a significant therapeutic approach for medically refractory craniocervical dystonia. The commonly utilized DBS targets are the Globus Pallidus internus (GPi) and the Subthalamic Nucleus (STN). Current research indicates no significant difference in efficacy between these two targets, although there are some differences in the onset time, stimulation voltage, and complications. Studies utilizing magnetic resonance imaging (MRI) to assess brain activity differences in patients with dystonia have found that patients exhibit increased activity and enhanced plasticity across a broad range of brain regions, including the brainstem, cortex, subcortical structures, and the basal ganglia, among others. Consequently, an increasing number of studies are classifying dystonia within the spectrum of brain network disorders. This study aims to recruit patients with craniocervical dystonia who meet the inclusion criteria, randomly assigning them into two groups of 30 patients each. One group will receive stimulation targeting the STN, and the other will target the GPi. Using functional MRI, researcher will conduct a dynamic brain network analysis to explore the differences in the brain network mechanisms underlying the treatment of craniocervical dystonia patients between the STN and GPi targets.

Primary Outcome Measures: resting-state functional magnetic resonance imaging data, First, all participants underwent a standardized rs-fMRI scan for data collection of resting-state BOLD signals. Secondly, data preprocessing was carried out, including head movement correction, non-brain tissue removal, temporal layer correction, spatial normalization, filtering, and removal of physiological noise. Then, the brain network was constructed based on the pre-processed data and the structural features of the brain network were identified. Finally, statistical analysis was used to compare the differences in brain network characteristics between the two groups., Change from baseline at 1, 6，12 months and 24 months
Secondary Outcome Measures: Burke-Fahn-Marsden Scale (BFMDRS), This scale was used to evaluate the severity of dystonia in the subjects, with a total score of 120 points, with higher scores indicating greater symptom severity, Change from baseline at 1, 6，12 months and 24 months|Toronto West Spasmodic Torticollis Rating Scale Scale(TWSTRS), The total score ranges from 0 to 85, with higher scores indicating more severe disease symptoms, Change from baseline at 1, 6，12 months and 24 months|Craniocervical Dystonia Questionnaire, The questionnaire each entry into 0 (never) - 4 points (always), higher scores on behalf of the increasingly serious damage, Change from baseline at 1, 6，12 months and 24 months|Frenchay dysarthria scale, The scale is divided into 28, each fine items according to the severity was divided into a to e grade 5, Change from baseline at 1, 6，12 months and 24 months|Watian Drinking Experiment, The Watian Drinking Experiment was used to evaluate the swallowing function of the subjects on a 5-point scale, and the normal level was 1 (swallow water within 5 seconds). Suspicious for level 1 (more than 5 seconds will swallow water) or level 2; Exception for 3 \~ 5, Change from baseline at 1, 6，12 months and 24 months|Number of Deep Brain Stimulation programming, The number of times participants were programmed after DBS, Change from baseline at 1, 6，12 months and 24 months|Number of side effects in Deep Brain Stimulation programming, Change from baseline at 1, 6，12 months and 24 months