NCT05416905 Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN
| NCT ID | NCT05416905 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Craniofacial Dystonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2022-06-22 |
| Primary Completion | 2025-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2022-06-22 with a primary completion date of 2025-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 postoperatively in patients with idiopathic craniofacial dystonia.
Eligibility Criteria
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.).
Contact & Investigator
Jianguo Zhang, MD, PhD
STUDY CHAIR
Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT05416905 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Craniofacial Dystonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05416905 currently recruiting?
Yes, NCT05416905 is actively recruiting participants. Contact the research team at baiyutong88@qq.com for enrollment information.
Where is the NCT05416905 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05416905 clinical trial?
NCT05416905 is sponsored by Beijing Tiantan Hospital. The principal investigator is Jianguo Zhang, MD, PhD at Beijing Tiantan Hospital. The trial plans to enroll 110 participants.