STN-DBS: The patients will be treated with deep brain electrode placement of STN target under local and general anesthesia. Switching the system on: the stimulator will be switched on 3 weeks after surgery to allow time for the brain edema and "stun effect" to wear off. Postoperative medication: The subject taking medication in the past will continue the medication. If the subject with no medication before, will be required not to take medication related to dystonia.
GPi-DBS: The patients will be treated with deep brain electrode implantation of GPi target under local and general anesthesia. Except that the surgical target was GPi, the operation process, stimulator switch-on time, and postoperative medication were the same as those in the STN-DBS group.
Study 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 postoperatively in patients with idiopathic craniofacial dystonia.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Adult subject (male or female, 18-75 years);
2. 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;
3. Treated with oral drugs or botulinum toxin injections, but with no satisfactory curative effect;
4. Normal cognitive function with MMSE score ≥ 24;
5. Informed consent signed.
Exclusion Criteria:
1. Only cervical dystonia, or combined with dystonia in other parts of the body other than the cervical region;
2. Diagnosed with other neuropsychiatric diseases(Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.);
3. History of brain surgery;
4. Severe depression with HRSD score ≥ 35;
5. Contraindications to neurosurgery(cerebral infarction, hydrocephalus, cerebral atrophy, sequelae of cerebrovascular disease, etc);
6. Contraindications to CT or MRI scanning(claustrophobia, etc);
7. pregnant or breastfeeding female, or has positive pregnancy test prior to randomization;
8. Contraindications to general anesthesia (severe arrhythmia, severe anemia, abnormal liver and kidney function, etc.);
9. Expected lifetime \< 12 months;
10. Currently receiving an investigational drug or device;
11. 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.).
Primary outcome measure(s)
Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 365 — 365 days postoperatively compared between groups Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-M contains 4 items of 0-40 and higher scores indicate a worse outcome.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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