Clinical trial NCT06912282: Bilateral Single-Electrode VO Combined With STN-DBS for Treating Meige Syndrome
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meige Syndrome
Keywords: DBS
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Improvement of primary symptoms
timeFrame: 1 year after stimulation
Secondary outcomes:
measure: Improvement of symptoms
timeFrame: 1 year after stimulation
measure: Improvement of symptoms
timeFrame: 1 year after stimulation
measure: Improvement of symptoms
timeFrame: 1 year after stimulation
measure: Improvement of symptoms
timeFrame: 1 year after stimulation
measure: Psychological assessment
timeFrame: 1 year after stimulation
measure: Psychological assessment
timeFrame: 1 year after stimulation
measure: Cognitive assessment
timeFrame: 1 year after stimulation
measure: Cognitive assessment
timeFrame: 1 year after stimulation
measure: health-related quality of life
timeFrame: 1 year after stimulation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University.
state: Shanghai
Study officials:
References: