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

NCT06480188 | Recruiting DMC

• 1 other identifier: 2024KY-102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystonia

Outcome Measures

Primary Outcomes (1)

• resting-state functional magnetic resonance imaging data

  First, all participants underwent a standardized rs-fMRI scan for data collection of resting-state BOLD signals. Secondly, data preprocessing was carried out, including head movement correction, non-brain tissue removal, temporal layer correction, spatial normalization, filtering, and removal of physiological noise. Then, the brain network was constructed based on the pre-processed data and the structural features of the brain network were identified. Finally, statistical analysis was used to compare the differences in brain network characteristics between the two groups.

  Change from baseline at 1, 6，12 months and 24 months

Secondary Outcomes (7)

• Burke-Fahn-Marsden Scale (BFMDRS)

  Change from baseline at 1, 6，12 months and 24 months

• Toronto West Spasmodic Torticollis Rating Scale Scale(TWSTRS)

  Change from baseline at 1, 6，12 months and 24 months

• Craniocervical Dystonia Questionnaire

  Change from baseline at 1, 6，12 months and 24 months

• Frenchay dysarthria scale

  Change from baseline at 1, 6，12 months and 24 months

• Watian Drinking Experiment

  Change from baseline at 1, 6，12 months and 24 months

Study Arms (2)

Group A

EXPERIMENTAL

GPi-DBS group

Device: deep brain stimulation

Group B

EXPERIMENTAL

STN-DBS group

Device: deep brain stimulation

Interventions

deep brain stimulation DEVICE

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

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Meeting the diagnostic criteria for primary craniocervical dystonia (including patients with cranial, cervical, or unilateral extremity dystonia)
• Disease duration ≥1 year
• Normal cognitive function
• The subject himself or his legal representative can sign the informed consent form

You may not qualify if:

• Diagnosed with other neuropsychiatric diseases (Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.)
• Previous history of craniocerebral surgery
• Major depression or anxiety
• The presence of neurosurgical contraindications such as cerebral infarction, hydrocephalus, cerebral atrophy, and sequelae of cerebrovascular disease
• Contraindications to CT/MRI scanning (e.g. Claustrophobia)
• women known to be pregnant or lactating, or who had a positive pregnancy test before randomization
• Presence of contraindications to general anesthesia (such as severe arrhythmia, severe anemia, abnormal liver and kidney function, etc.)
• Expected survival less than 12 months
• has participated in other interventional clinical studies that may have affected the outcome assessment
• other circumstances considered by the investigator to be inappropriate for participation in the study or likely to pose a significant risk to the patient

Sponsors & Collaborators

• Anhui Provincial Hospital: lead
• Beijing Pins Medical Co., Ltd: collaborator

Study Sites (1)

The First Affiliated Hospital of Ustc

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Dystonia

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Chaoshi Niu

CONTACT

13855186208; niuchaoshi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Device: Deep Brain Stimulation (DBS) of Gpi，PINS G106R Device: Deep Brain Stimulation (DBS) of STN，PINS G106R

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 28, 2024
• Study Start: March 1, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: July 8, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)