Multicenter Evaluation of Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: Globus Pallidus intErnus or Subthalamic Nucleus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 365
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.).
结局指标
主要结局
Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 365
时间窗: 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.
次要结局
- Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 90(90 days postoperatively compared between groups)
- Hamilton depression scale (HRSD) difference(365 days postoperatively compared between groups)
- Montreal cognitive assessment (MoCA) difference(365 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)
- Programming parameters difference(365 days postoperatively compared between groups)
- Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 180(180 days postoperatively compared between groups])
- Hamilton anxiety scale (HAMA) difference(365 days postoperatively compared between groups)
- Jankovic rating scale (JRS) difference(365 days postoperatively compared between groups)
- Mini-mental state examination (MMSE) difference(365 days postoperatively compared between groups)
- Medical outcomes study shortform-36 (SF-36) difference(365 days postoperatively compared between groups)
研究者
Jianguo Zhang
Director of Department of Functional Neurosurgery
Beijing Tiantan Hospital