Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN

NCT05416905 | Recruiting DMC

• 1 other identifier: HX-A-2022022
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Craniofacial Dystonia; Deep Brain Stimulation; Globus pallidus internus; Subthalamic nucleus

Outcome Measures

Primary Outcomes (1)

• Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 365

  Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-M contains 4 items of 0-40 and higher scores indicate a worse outcome.

  365 days postoperatively compared between groups

Secondary Outcomes (11)

• Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 90

  90 days postoperatively compared between groups

• Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 180

  180 days postoperatively compared between groups]

• Burke-Fahn-Marsden dystonia rating scale-disability score (BFMDRS-D) difference

  365 days postoperatively compared between groups

• Blepharospasm disability index (BDSI) difference

  365 days postoperatively compared between groups

• Jankovic rating scale (JRS) difference

  365 days postoperatively compared between groups

Study Arms (2)

STN-DBS

EXPERIMENTAL

The patients in this group will be treated with STN-DBS.

Device: STN-DBS

GPi-DBS

ACTIVE COMPARATOR

The patients in this group will be treated with GPi-DBS.

Device: GPi-DBS

Interventions

STN-DBS DEVICE

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.

Also known as: subthalamic necleus-deep brain stimulation

STN-DBS

GPi-DBS DEVICE

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.

Also known as: globus pallidus internus-deep brain stimulation

GPi-DBS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Contraindications to neurosurgery(cerebral infarction, hydrocephalus, cerebral atrophy, sequelae of cerebrovascular disease, etc);
• Contraindications to CT or MRI scanning(claustrophobia, etc);
• pregnant or breastfeeding female, or has positive pregnancy test prior to randomization;
• Contraindications to general anesthesia (severe arrhythmia, severe anemia, abnormal liver and kidney function, etc.);
• Expected lifetime \< 12 months;
• Currently receiving an investigational drug or device;
• Other circumstances that the investigator considers unsuitable to participate in this study or that may pose a significant risk to the patient (inability to understand or comply with research procedures and follow-up, etc.).

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• 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

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

RECRUITING

Study Officials

• Jianguo Zhang, MD, PhD

  Beijing Tiantan Hospital

  STUDY CHAIR

Central Study Contacts

Yutong Bai, MD, PhD

CONTACT

13611420134; baiyutong88@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Functional Neurosurgery

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: June 22, 2022
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)