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

Fudan University

Status: Enrolling

Conditions: Meige Syndrome

Treatments: Device: deep brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06912282

KY2025-084

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

VO-DBS / VO Combined with STN-DBS Group

Experimental group

Description:

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.

Treatment:

Device: deep brain stimulation

STN-DBS / VO Combined with STN-DBS Group

Active Comparator group

Description:

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.

Treatment:

Device: deep brain stimulation