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

Last updated: July 4, 2024
Sponsor: Anhui Provincial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dyskinesias

Dystonia

Treatment

deep brain stimulation

Clinical Study ID

NCT06480188
2024KY-102
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-75 years

  2. Meeting the diagnostic criteria for primary craniocervical dystonia (includingpatients with cranial, cervical, or unilateral extremity dystonia)

  3. Disease duration ≥1 year

  4. Normal cognitive function

  5. The subject himself or his legal representative can sign the informed consent form

Exclusion

Exclusion Criteria:

  1. Patients with other dystonia who did not meet the inclusion criteria

  2. Diagnosed with other neuropsychiatric diseases (Alzheimer's disease, amyotrophiclateral sclerosis, Parkinson's disease, etc.)

  3. Previous history of craniocerebral surgery

  4. Major depression or anxiety

  5. The presence of neurosurgical contraindications such as cerebral infarction,hydrocephalus, cerebral atrophy, and sequelae of cerebrovascular disease

  6. Contraindications to CT/MRI scanning (e.g. Claustrophobia)

  7. women known to be pregnant or lactating, or who had a positive pregnancy test beforerandomization

  8. Presence of contraindications to general anesthesia (such as severe arrhythmia,severe anemia, abnormal liver and kidney function, etc.)

  9. Expected survival less than 12 months

  10. has participated in other interventional clinical studies that may have affected theoutcome assessment

  11. other circumstances considered by the investigator to be inappropriate forparticipation in the study or likely to pose a significant risk to the patient

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: deep brain stimulation
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Ustc

    Hefei, Anhui
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.