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RECRUITING
NCT05416905
NA

Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2022-06-22

Completion Date

2025-05-30

Last Updated

2025-04-22

Healthy Volunteers

No

Interventions

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.

Locations (1)

Beijing Tiantan Hospital

Beijing, China