MedTrace Logo

Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN

NCT05416905 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-04-22

No results posted yet for this study

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.

Conditions

  • Craniofacial Dystonia
  • Deep Brain Stimulation

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Peking University People's Hospital

    collaborator OTHER

  • Civil Aviation General Hospital

    collaborator OTHER

  • Chinese PLA General Hospital

    collaborator OTHER

  • Beijing Pins Medical Co., Ltd

    collaborator INDUSTRY

  • Shandong University of Traditional Chinese Medicine

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Beijing Fengtai Hospital

    collaborator UNKNOWN

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Jianguo Zhang, MD, PhD · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2025-05-30
Completion
2025-05-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05416905 on ClinicalTrials.gov