Bilateral Single-Electrode VO Combined With STN-DBS for Treating Meige Syndrome

Not Applicable

Recruiting

• Conditions: Meige Syndrome

• Registration Number: NCT06912282
• Lead Sponsor: Huashan Hospital

Brief Summary

Meige syndrome is a rare and debilitating movement disorder characterized by blepharospasm, oromandibular dystonia, and cervical muscle contractions, often refractory to pharmacological therapies. Deep brain stimulation (DBS), initially developed to treat essential tremor and Parkinson's disease, has been explored in recent years as a potential treatment for various dystonias, including Meige's syndrome. This clinical study aims to evaluate the safety and efficacy of bilateral single-electrode ventralis oralis (VO) nucleus stimulation combined with subthalamic nucleus deep brain stimulation (STN-DBS) in patients with Meige syndrome.

Detailed Description

While deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) or the globus pallidus interna (GPi) has shown moderate efficacy, incomplete symptom relief and high stimulation thresholds with associated side effects remain significant limitations. Emerging evidence suggests that dual-target neuromodulation combining STN with ventralis oralis (VO) nucleus stimulation may synergistically modulate hyperactive basal ganglia-thalamocortical circuits, potentially enhancing therapeutic outcomes.The study will involve patients diagnosed with Meige syndrome who are eligible for DBS therapy. Participants will be randomly assigned to one of two groups.The primary outcome measure is the improvement in motor symptoms, assessed using the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) before and after treatment. Secondary outcomes will include changes in quality of life, anxiety and depression scores, and any adverse effects related to the DBS procedure.The results of this study will be used to guide future clinical trials and inform the treatment options for patients with Meige syndrome.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-06
• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-03-30
• Last Update Submitted: 2025-03-30
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-06-30
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Must meet the clinical diagnostic criteria for Meige syndrome
• Only includes patients with: Blepharospasm-type Meige syndrome and Blepharospasm with lower jaw muscle dystonia-type
• All patients must have undergone at least one year of systematic and standard treatment prior to surgery

Exclusion Criteria

• History of neurological diseases other than Meige syndrome
• Severe cognitive impairment
• Severe psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement of primary symptoms	1 year after stimulation	Scale title: Burke-Fahn-Marsden Dystonia Rating Scale Section I: Motor subscale (0-120) Section II: Disability scale (0-30) Higher scores: Indicate worse outcomes (more severe dystonia symptoms).

Secondary Outcome Measures

Name	Time	Method
Improvement of symptoms	1 year after stimulation	Scale title: Oromandibular Dystonia Rating Scale Minimum value: 0 (No dystonia) Maximum value: 314 (Severe dystonia) Higher scores: Indicate worse outcomes (more severe oromandibular dystonia symptoms).
Psychological assessment	1 year after stimulation	Scale title: Hamilton Depression Rating Scale Minimum value: 0 (No depression) Maximum value: 52 (Severe depression) Higher scores: Indicate worse outcomes (more severe depression).
Cognitive assessment	1 year after stimulation	Scale title: Montreal Cognitive Assessment Minimum value: 0 (Severe cognitive impairment) Maximum value: 30 (No cognitive impairment) Higher scores: Indicate better outcomes (better cognitive function).
health-related quality of life	1 year after stimulation	Scale title:Short Form 36 Health Survey; The SF-36 is a widely used tool to assess general health status and quality of life. It includes 36 items that measure eight health domains: Physical functioning Role limitations due to physical health problems Role limitations due to emotional problems Energy/fatigue Emotional well-being Social functioning Pain General health perceptions Each of the domains is scored separately, and the overall score can reflect a person's physical and mental health.; Minimum value: 0 (Worst health status) Maximum value: 100 (Best health status) Higher scores: Indicate better outcomes (better health-related quality of life).

Trial Locations

Locations (1)

Huashan Hospital, Fudan University.; 🇨🇳 Shanghai, Shanghai, China