Status:
RECRUITING
Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
Peking Union Medical College Hospital
Peking University People's Hospital
Conditions:
Craniofacial Dystonia
Deep Brain Stimulation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 postoperativ...
Detailed Description
Evaluating therapeutic effects of GPi-DBS vs. STN-DBS on patients with idiopathic craniofacial dystonia: Clinical data of patients at different treatment time points will be collected, using different...
Eligibility Criteria
Inclusion
- Adult subject (male or female, 18-75 years);
- Diagnosed with idiopathic craniofacial dystonia for more than 1 year, including at least one of the eye and oromandibular region. Cervical dystonia may be present;
- Treated with oral drugs or botulinum toxin injections, but with no satisfactory curative effect;
- Normal cognitive function with MMSE score ≥ 24;
- Informed consent signed.
Exclusion
- Only cervical dystonia, or combined with dystonia in other parts of the body other than the cervical region;
- Diagnosed with other neuropsychiatric diseases(Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.);
- History of brain surgery;
- Severe depression with HRSD score ≥ 35;
- Contraindications to neurosurgery(cerebral infarction, hydrocephalus, cerebral atrophy, sequelae of cerebrovascular disease, etc);
- Contraindications to CT or MRI scanning(claustrophobia, etc);
- pregnant or breastfeeding female, or has positive pregnancy test prior to randomization;
- Contraindications to general anesthesia (severe arrhythmia, severe anemia, abnormal liver and kidney function, etc.);
- Expected lifetime \< 12 months;
- Currently receiving an investigational drug or device;
- Other circumstances that the investigator considers unsuitable to participate in this study or that may pose a significant risk to the patient (inability to understand or comply with research procedures and follow-up, etc.).
Key Trial Info
Start Date :
June 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05416905
Start Date
June 22 2022
End Date
May 30 2025
Last Update
April 22 2025
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, China