Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN

Official title

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

Overview

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.

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.

Primary outcome measures

• Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 365 [Time frame: 365 days postoperatively compared between groups]

Secondary outcome measures (11)

• Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 90 [Time frame: 90 days postoperatively compared between groups]
• Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 180 [Time frame: 180 days postoperatively compared between groups]]
• Burke-Fahn-Marsden dystonia rating scale-disability score (BFMDRS-D) difference [Time frame: 365 days postoperatively compared between groups]
• Blepharospasm disability index (BDSI) difference [Time frame: 365 days postoperatively compared between groups]
• Jankovic rating scale (JRS) difference [Time frame: 365 days postoperatively compared between groups]
• Mini-mental state examination (MMSE) difference [Time frame: 365 days postoperatively compared between groups]
• Montreal cognitive assessment (MoCA) difference [Time frame: 365 days postoperatively compared between groups]
• Hamilton depression scale (HRSD) difference [Time frame: 365 days postoperatively compared between groups]
• Hamilton anxiety scale (HAMA) difference [Time frame: 365 days postoperatively compared between groups]
• Medical outcomes study shortform-36 (SF-36) difference [Time frame: 365 days postoperatively compared between groups]
• Programming parameters difference [Time frame: 365 days postoperatively compared between groups]

Eligibility criteria

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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT05416905 · HX-A-2022022

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗