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NCT Number: NCT05416905

Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN

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.

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Key information

Conditions

Craniofacial Dystonia Deep Brain Stimulation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.).

Treatment and study plan

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.

Other names: subthalamic necleus-deep brain stimulation

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.

Other names: globus pallidus internus-deep brain stimulation

Primary outcomes

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

    Time frame: 365 days postoperatively compared between groups

    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.

Secondary outcomes

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

    Time frame: 90 days postoperatively compared between groups

    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 90 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.

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

    Time frame: 180 days postoperatively compared between groups]

    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 180 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.

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

    Time frame: 365 days postoperatively compared between groups

    Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-disability score (BFMDRS-D) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-D contains 7 items of 0-30 and higher scores indicate a worse outcome.

  4. Blepharospasm disability index (BDSI) difference

    Time frame: 365 days postoperatively compared between groups

    Differences between the two groups in the change of Blepharospasm disability index (BDSI) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. BDSI contains 6 items of 0-4 (average socre) and higher scores indicate a worse outcome.

  5. Jankovic rating scale (JRS) difference

    Time frame: 365 days postoperatively compared between groups

    Differences between the two groups in the change of Jankovic rating scale (JRS) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. JRS contains 2 items of 0-8 and higher scores indicate a worse outcome.

  6. Mini-mental state examination (MMSE) difference

    Time frame: 365 days postoperatively compared between groups

    Differences between the two groups in the change of mini-mental state examination (MMSE) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. MMSE contains 30 questions of 0-30 and higher scores indicate a better outcome.

  7. Montreal cognitive assessment (MoCA) difference

    Time frame: 365 days postoperatively compared between groups

    Differences between the two groups in the change of Montreal cognitive assessment (MoCA) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. MoCA contains 8 modules of 0-30 and higher scores indicate a better outcome.

  8. Hamilton depression scale (HRSD) difference

    Time frame: 365 days postoperatively compared between groups

    Differences between the two groups in the change of Hamilton depression scale (HRSD) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. HRSD contains 24 items of 24-77 and higher scores indicate a worse outcome.

  9. Hamilton anxiety scale (HAMA) difference

    Time frame: 365 days postoperatively compared between groups

    Differences between the two groups in the change of Hamilton anxiety scale (HAMA) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. HAMA contains 14 items of 0-56 and higher scores indicate a worse outcome.

  10. Medical outcomes study shortform-36 (SF-36) difference

    Time frame: 365 days postoperatively compared between groups

    Differences between the two groups in the change of medical outcomes study shortform-36 (SF-36) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. SF-36 contains 8 modules of 0-100 and higher scores indicate a better outcome.

  11. Programming parameters difference

    Time frame: 365 days postoperatively compared between groups

    Differences between the two groups in programming parameters change scores in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment, including total electrical energy delivered (TEED), contact, voltage, pulse width and frequency.

Study contacts

Contact information is provided by the study sponsor or research team.

Yutong Bai, MD, PhD

CONTACT

[email protected]

13611420134

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Fengtai Hospital
  • Beijing Pins Medical Co., Ltd
  • Chinese PLA General Hospital
  • Civil Aviation General Hospital
  • Peking Union Medical College Hospital
  • Peking University People's Hospital
  • Qilu Hospital of Shandong University
  • Shandong University of Traditional Chinese Medicine

Registry information

Official study title

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

Acronym: MEIGES

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2022
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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