Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05416905, who can take part
Where in China
- Beijing Tiantan HospitalBeijing, ChinaContact: Jianguo Zhang, MD, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Beijing Tiantan Hospital
- Trial code
- NCT05416905
- Record updated
- 22 April 2025
- Original description
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.Read full original descriptionShow less
Multicenter Evaluation of Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: Globus Pallidus intErnus or Subthalamic Nucleus
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.
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: pregnant or breastfeeding female, or has positive pregnancy test prior to randomization; Currently receiving an investigational drug or device; Diagnosed with other neuropsychiatric diseases(Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.); History of brain surgery; Contraindications to neurosurgery(cerebral infarction, hydrocephalus, cerebral atrophy, sequelae of cerebrovascular disease, etc); Contraindications to general anesthesia (severe arrhythmia, severe anemia, abnormal liver and kidney function, etc.); Only cervical dystonia, or combined with dystonia in other parts of the body other than the cervical region; Severe depression with HRSD score ≥ 35; Contraindications to CT or MRI scanning(claustrophobia, etc); Expected lifetime < 12 months; 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.).