Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Tiantan Hospital
About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- STN-DBS
- GPi-DBS
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Beijing Tiantan Hospital
Lead sponsor
Peking Union Medical College Hospital
Collaborator
Peking University People's Hospital
Collaborator
Civil Aviation General Hospital
Collaborator
Chinese PLA General Hospital
Collaborator
Beijing Pins Medical Co., Ltd
Collaborator
Shandong University of Traditional Chinese Medicine
Collaborator
Qilu Hospital of Shandong University
Collaborator
Beijing Fengtai Hospital
Collaborator
Source ClinicalTrials.gov