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

Last updated: March 30, 2025
Sponsor: Huashan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

deep brain stimulation

Clinical Study ID

NCT06912282
KY2025-084
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must meet the clinical diagnostic criteria for Meige syndrome

  • Only includes patients with: Blepharospasm-type Meige syndrome and Blepharospasmwith lower jaw muscle dystonia-type

  • All patients must have undergone at least one year of systematic and standardtreatment prior to surgery

Exclusion

Exclusion Criteria:

  • History of neurological diseases other than Meige syndrome

  • Severe cognitive impairment

  • Severe psychiatric disorders

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: deep brain stimulation
Phase:
Study Start date:
March 06, 2025
Estimated Completion Date:
January 01, 2027

Study 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.

Connect with a study center

  • Huashan Hospital, Fudan University.

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.