Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06480188

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

Led by Anhui Provincial Hospital · Updated on 2024-07-08

60

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

Sponsors

A

Anhui Provincial Hospital

Lead Sponsor

B

Beijing Pins Medical Co., Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-75 years
  • Diagnosis of primary craniocervical dystonia including cranial, cervical, or unilateral limb dystonia
  • Disease duration of at least 1 year
  • Normal cognitive function
  • Ability to provide informed consent by the participant or their legal representative
Not Eligible

You will not qualify if you...

  • Diagnosis of other dystonia types not meeting inclusion criteria
  • Presence of other neuropsychiatric diseases such as Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease
  • Previous craniocerebral surgery
  • Major depression or anxiety
  • Neurosurgical contraindications like cerebral infarction, hydrocephalus, cerebral atrophy, or cerebrovascular disease sequelae
  • Contraindications to CT/MRI scanning such as claustrophobia
  • Pregnant or lactating women or positive pregnancy test before randomization
  • Contraindications to general anesthesia including severe arrhythmia, anemia, or abnormal liver/kidney function
  • Expected survival less than 12 months
  • Participation in other interventional clinical studies affecting outcome assessment
  • Other conditions deemed inappropriate or risky by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Ustc

Hefei, Anhui, China

Actively Recruiting

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Research Team

C

Chaoshi Niu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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