Actively Recruiting
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
Led by Huashan Hospital · Updated on 2025-04-04
20
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Meige syndrome is a rare and challenging movement disorder that causes involuntary muscle contractions affecting the eyes, jaw, and neck. It often does not respond well to medications. Researchers are studying the safety and effects of a new approach using deep brain stimulation (DBS) targeting two brain areas: the ventralis oralis (VO) nucleus and the subthalamic nucleus (STN) in patients with Meige syndrome to potentially improve symptoms. Participants will receive surgery to implant electrodes in both brain areas. After the device is turned on, one group will first receive stimulation only in the VO area, and the other group will receive stimulation only in the STN area. After three months, both groups will receive combined stimulation in both brain targets. This study is randomized and double-blind to compare the effects of these treatments. Participants will be evaluated for symptom improvement using the Burke-Fahn-Marsden Dystonia Rating Scale over one year after stimulation begins. Other assessments include quality of life, anxiety, depression, and cognitive tests. Researchers will monitor any side effects related to the DBS procedure. The study results aim to guide future treatment options for Meige syndrome.
CONDITIONS
Brief Title
Bilateral Single-Electrode VO Combined With STN-DBS for Treating Meige Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must meet the clinical diagnostic criteria for Meige syndrome
- Have blepharospasm-type Meige syndrome or blepharospasm with lower jaw muscle dystonia
- Have undergone at least one year of systematic and standard treatment before surgery
You will not qualify if you...
- History of neurological diseases other than Meige syndrome
- Severe cognitive impairment
- Severe psychiatric disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo bilateral single-electrode VO combined with STN target implantation and device activation.
1 visit (in-person)
Duration - Up to 1 year
Participants receive initial single-target stimulation (VO-DBS or STN-DBS) for 3 months, followed by combined VO and STN-DBS stimulation to manage Meige syndrome symptoms.
Regular follow-up visits during the year of stimulation
Trial Site Locations
Total: 1 location
1
Huashan Hospital, Fudan University.
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here