An interventional study of deep brain stimulation in Meige Syndrome, sponsored by Huashan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Huashan Hospital · Not applicable, Interventional, and Treatment
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.
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.
Huashan Hospital is the lead sponsor of 247 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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).
Time frame: 1 year after stimulation
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 1 year after stimulation
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Jun 2026, 15 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Meige Syndrome