NCT05416905

Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN

Multicenter Evaluation of Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: Globus Pallidus intErnus or Subthalamic Nucleus

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Evaluating therapeutic effects of GPi-DBS vs. STN-DBS on patients with idiopathic craniofacial dystonia: Clinical data of patients at different treatment time points will be collected, using different clinical assessments. The main purpose is to assess whether STN-DBS is non-inferior to GPi-DBS for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia. Primary endpoints: Differences between the two groups in BFMDRS-M change scores in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS. Secondary endpoints: Differences between the two groups in BFMDRS-M change scores in the stimulation state from before to 90, 180 days (±14 days) after STN-DBS and GPi-DBS. Differences between the two groups in BFMDRS-D, BDSI, JRS, MMSE, MoCA, HRSD, HAMA, SF-36 and programming parameters change scores in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS.

Conditions

• Craniofacial Dystonia
• Deep Brain Stimulation

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2022-06-22
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2022-06-14
• Last updated: 2025-04-22

Locations

1 site across 1 country: China