Actively Recruiting
Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN
Led by Beijing Tiantan Hospital · Updated on 2025-04-22
110
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
MEIGES is a prospective, multicenter, randomized controlled clinical trial with the primary hypothesis that, STN-DBS is non-inferior to GPi-DBS for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia.
CONDITIONS
Official Title
Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with idiopathic craniofacial dystonia for more than 1 year involving eye or oromandibular regions; cervical dystonia may be present
- Previously treated with oral drugs or botulinum toxin injections without satisfactory effect
- Normal cognitive function with an MMSE score of 24 or higher
- Signed informed consent
You will not qualify if you...
- Only cervical dystonia or dystonia involving other body parts excluding the cervical region
- Diagnosed with other neuropsychiatric diseases such as Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease
- History of brain surgery
- Severe depression with HRSD score 35 or higher
- Contraindications to neurosurgery (including cerebral infarction, hydrocephalus, cerebral atrophy, cerebrovascular disease sequelae)
- Contraindications to CT or MRI scans (including claustrophobia)
- Pregnant or breastfeeding female, or positive pregnancy test before randomization
- Contraindications to general anesthesia (including severe arrhythmia, severe anemia, abnormal liver or kidney function)
- Expected lifetime less than 12 months
- Currently receiving an investigational drug or device
- Other conditions deemed unsuitable by the investigator or posing significant risk, including inability to understand or comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yutong Bai, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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