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

Evaluation of Bilateral Single-Electrode VO Combined With STN-DBS Stimulation in the Treatment of Meige Syndrome: A Prospective, Single-Center, Double-Blind, Randomized Controlled Exploratory Clinical Study

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.

Study Overview

• Status: Recruiting
• Conditions: Meige Syndrome
• Intervention / Treatment: Device: deep brain stimulation

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital, Fudan University.
      • Contact: Chunhao Zhang; Phone Number: +86-21-52889999; Email: 24111220163@m.fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VO-DBS / VO Combined with STN-DBS Group; Patients will undergo bilateral single-electrode VO combined with STN target implantation. After device activation, VO-DBS single-target stimulation will be applied. Evaluation will be conducted after three months, followed by the initiation of combined VO and STN-DBS stimulation.	Device: deep brain stimulation; bilateral single-electrode VO combined with STN target implantation
Active Comparator: STN-DBS / VO Combined with STN-DBS Group; Patients will undergo bilateral single-electrode VO combined with STN target implantation. After device activation, STN-DBS single-target stimulation will be applied. Evaluation will be conducted after three months, followed by the initiation of combined VO and STN-DBS stimulation.	Device: deep brain stimulation; bilateral single-electrode VO combined with STN target implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of primary symptoms	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).	1 year after stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of symptoms	Scale title: Jankovic Rating Scale Minimum value: 0 (No dystonia) Maximum value: 8 (Severe dystonia) Higher scores: Indicate worse outcomes (more severe dystonia symptoms).	1 year after stimulation
Improvement of symptoms	Scale title: Blepharospasm Disability Index Minimum value: 0 (No disability) Maximum value: 24 (Severe disability) Higher scores: Indicate worse outcomes (more severe disability due to blepharospasm).	1 year after stimulation
Improvement of symptoms	Scale title: Oromandibular Dystonia Questionnaire Minimum value: 0 (No symptoms or disability) Maximum value: 100 (Severe disability) Higher scores: Indicate worse outcomes (more disability due to oromandibular dystonia).	1 year after stimulation
Improvement of symptoms	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).	1 year after stimulation
Psychological assessment	Scale title: Hamilton Anxiety Rating Scale Minimum value: 0 (No anxiety) Maximum value: 56 (Severe anxiety) Higher scores: Indicate worse outcomes (more severe anxiety).	1 year after stimulation
Psychological assessment	Scale title: Hamilton Depression Rating Scale Minimum value: 0 (No depression) Maximum value: 52 (Severe depression) Higher scores: Indicate worse outcomes (more severe depression).	1 year after stimulation
Cognitive assessment	Scale title: Mini-Mental State Examination Minimum value: 0 (Severe cognitive impairment) Maximum value: 30 (No cognitive impairment) Higher scores: Indicate better outcomes (better cognitive function).	1 year after stimulation
Cognitive assessment	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).	1 year after stimulation
health-related quality of life	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).	1 year after stimulation

Collaborators and Investigators

• Sponsor: Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 30, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: March 30, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: DBS
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Disease; Movement Disorders; Basal Ganglia Diseases; Dystonic Disorders; Syndrome; Meige Syndrome
• Other Study ID Numbers: KY2025-084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No