NCT06480188

Differences in Brain Network Mechanisms Between STN and GPi Deep Brain Stimulation in the Treatment of Craniocervical Dystonia

Differences in Brain Network Mechanisms Between STN and GPi Deep Brain Stimulation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objectives of this study are: 1) to explore the differences of brain network mechanisms between STN and GPi targets in craniocervical dystonia; 2. To explore the effects of DBS on dysarthsia and dysphagia in patients with craniocervical dystonia and the differences in efficacy, quality of life and side effects between GPi and STN targets in the treatment of craniocervical dystonia; 3. To explore the differences in the electrophysiological signals of nuclei collected during DBS surgery and their application in programming.

Conditions

• Dystonia

Interventions

Type	Name	Description
DEVICE	deep brain stimulation	Group A was the GPi-DBS stimulation group； Group B was the STN-DBS stimulation group

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-06-28
• Last updated: 2024-07-08

Locations

1 site across 1 country: China