Bilateral Single-Electrode VO Combined With STN-DBS for Treating Meige Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: deep brain stimulation.
- Who it may be relevant to
- Registry conditions: Meige Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- Device deep brain stimulation
bilateral single-electrode VO combined with STN target implantation
Primary outcome measures
- Improvement of primary symptoms [Time frame: 1 year after stimulation]
Secondary outcome measures (9)
- Improvement of symptoms [Time frame: 1 year after stimulation]
- Improvement of symptoms [Time frame: 1 year after stimulation]
- Improvement of symptoms [Time frame: 1 year after stimulation]
- Improvement of symptoms [Time frame: 1 year after stimulation]
- Psychological assessment [Time frame: 1 year after stimulation]
- Psychological assessment [Time frame: 1 year after stimulation]
- Cognitive assessment [Time frame: 1 year after stimulation]
- Cognitive assessment [Time frame: 1 year after stimulation]
- health-related quality of life [Time frame: 1 year after stimulation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Huashan Hospital, Fudan University. — Shanghai
Identifiers
NCT: NCT06912282 · KY2025-084