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

NCT ID: NCT06480188

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A

GPi-DBS group

Group Type: EXPERIMENTAL

deep brain stimulation

Intervention Type: DEVICE

Group A was the GPi-DBS stimulation group； Group B was the STN-DBS stimulation group

Group B

STN-DBS group

Group Type: EXPERIMENTAL

deep brain stimulation

Intervention Type: DEVICE

Group A was the GPi-DBS stimulation group； Group B was the STN-DBS stimulation group

Interventions

deep brain stimulation

Group A was the GPi-DBS stimulation group； Group B was the STN-DBS stimulation group

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 18-75 years

2. Meeting the diagnostic criteria for primary craniocervical dystonia (including patients 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

2. Diagnosed with other neuropsychiatric diseases (Alzheimer's disease, amyotrophic lateral 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 before randomization

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 the outcome assessment

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Ustc

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chaoshi Niu

Role: CONTACT

niuchaoshi@163.com

13855186208

Facility Contacts

Chaoshi Niu

Role: primary

niuchaoshi@163.com

13855186208

Other Identifiers

2024KY-102

Identifier Type: -

Identifier Source: org_study_id