Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06912282

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Meige Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dystonic Disorders Movement Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huashan Hospital, Fudan University.

Shanghai, Shanghai Municipality, 200040, China

Location status: Recruiting

Location contact

Chunhao Zhang

CONTACT

[email protected]

+86-21-52889999

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep brain stimulation

Device

bilateral single-electrode VO combined with STN target implantation

Primary outcomes

  1. Improvement of primary symptoms

    Time frame: 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 outcomes

  1. Improvement of symptoms

    Time frame: 1 year after stimulation

    Scale title: Jankovic Rating Scale Minimum value: 0 (No dystonia) Maximum value: 8 (Severe dystonia) Higher scores: Indicate worse outcomes (more severe dystonia symptoms).

  2. Improvement of symptoms

    Time frame: 1 year after stimulation

    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).

  3. Improvement of symptoms

    Time frame: 1 year after stimulation

    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).

  4. Improvement of symptoms

    Time frame: 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).

  5. Psychological assessment

    Time frame: 1 year after stimulation

    Scale title: Hamilton Anxiety Rating Scale Minimum value: 0 (No anxiety) Maximum value: 56 (Severe anxiety) Higher scores: Indicate worse outcomes (more severe anxiety).

  6. Psychological assessment

    Time frame: 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).

  7. Cognitive assessment

    Time frame: 1 year after stimulation

    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).

  8. Cognitive assessment

    Time frame: 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).

  9. health-related quality of life

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.