Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480188
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-14
Brief Title:
Differences in Brain Network Mechanisms Between STN and GPi Deep Brain Stimulation in the Treatment of Craniocervical Dystonia
Sponsor:
Anhui Provincial Hospital
Organization:
Anhui Provincial Hospital
Study Overview
Official Title:
Differences in Brain Network Mechanisms Between STN and GPi Deep Brain Stimulation
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Craniocervical dystonia characterized by symptoms distributed in the craniofacial andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None