Multicenter Evaluation of Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: Globus Pallidus intErnus or Subthalamic Nucleus
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Beijing Tiantan Hospital
RECRUITING
Beijing
Contact Information
Primary
Yutong Bai, MD, PhD
baiyutong88@qq.com
13611420134
Time Frame
Start Date: 2022-06-22
Estimated Completion Date: 2025-05-30
Participants
Target number of participants: 110
Treatments
Experimental: STN-DBS
The patients in this group will be treated with STN-DBS.
Active_comparator: GPi-DBS
The patients in this group will be treated with GPi-DBS.
Related Therapeutic Areas
Sponsors
Collaborators: Beijing Fengtai Hospital, Qilu Hospital of Shandong University, Peking Union Medical College Hospital, Civil Aviation General Hospital, Shandong University of Traditional Chinese Medicine, Beijing Pins Medical Co., Ltd, Chinese PLA General Hospital, Peking University People's Hospital
Leads: Beijing Tiantan Hospital