Subthalamic Nucleus (STN) and Globus Pallidus Internus (GPi) Deep Brain Stimulation (DBS) in Patients With Primary Dystonia（RELAX Study）
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 7
- 主要终点
- change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) movement score
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation (DBS) of the subthalamic nucleus (STN) and globus pallidus internus (GPi) for primary dystonia.
详细描述
Dystonia is an uncommon brain disorder in which there is abnormal muscle tone producing twisting, writhing movements and abnormal postures. It is associated with abnormal electrical activity in two groups of nerve cells in the brain called the globus pallidus internus (GPi) and the subthalamic nucleus (STN). GPi DBS appears to be effective for medication-refractory focal and segmental dystonia affecting the cranial and cervical regions in open-label series, but recently GPi stimulation has been associated with subtle motor disturbances in previously non-dystonic body regions (i.e., arms and legs) in this population of patients. DBS of the STN has also been reported to be effective for treating generalized and cervical dystonia in small open label trials. STN DBS for cranial and cervical regions may provide similar efficacy in the treatment of dystonia as GPi DBS, but without unwanted stimulation-induced motor effects. Objectives of this study is to evaluate the safety and efficacy of STN-DBS and GPi-DBS for dystonia; Participants will be evaluated pre- and postoperatively with standard dystonia rating scales including the Burke-Fahn-Marsden Dystonia rating scale (BFMDRS), Changes in cognitive function will be assessed with neuropsychological testing. Stimulation parameters will be documented, and a patient questionnaire will be administered postoperatively to determine if patients are experiencing stimulation-induced motor adverse effects. Patient weight will be recorded at study visits. This pilot study will provide preliminary open label efficacy outcomes for STN DBS in the treatment of primary dystonia and will help determine if this target should be compared to GPi DBS in a larger double-blind trial.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractory primary (systemic, segmental) dystonia diagnosed by a movement disorders neurologist
- •Severe functional impairment despite optimal medical management, including failed botulinum toxin therapy
- •Ability to follow up with post-operative study visits
- •Patients and their relatives have reasonable surgery expectations
- •Volunteer to participate in clinical trials, and signed consent form
- •Age 6-60 years
排除标准
- •Pregnancy or plan a pregnancy
- •Good treatment with Non-invasive therapy
- •Dopamine reactive dystonia ，Genetic degeneration ，Paroxysmal dystonia ，Secondary dystonia， Psychogenic dystonia
- •Brain MRI showing extensive brain atrophy or small vessel ischemic disease
- •Cognitive impairment(MMSE<24)
- •Severe depression or other serious mental illness
- •History of traumatic brain injury, tumor, or severe cerebrovascular disease
- •Severe brain atrophy (diagnosed by CT or MRI)
- •Hyperthermia therapy in implant parts
- •Abnormal in blood inspection, blood clotting disorders, liver and kidney dysfunction, or other clinical judgment cannot tolerate surgery
- •High blood pressure, serious heart diseases, or respiratory diseases
- •Long-term treatment of immunosuppressive or hormones
- •Implant pacemakers, defibrillators, cochlear and other nerve stimulators
- •Other diseases need frequent MRI examinations
- •Participated in any other clinical trials within 3 months
- •Reluctant or unable to implant surgery
- •Reluctant or unable to cooperate with follow-up
- •Other exclusion Criteria by researchers
结局指标
主要结局
change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) movement score
时间窗: 3，6 months
次要结局
- Short-Form General Health Survey (SF-36)(3，6 monthsthe Beck Anxiety Inventory31 (with scores ranging from 0 to 63 and higher scores indicating more severe anxiety))
- Visual analogue scale(3，6 months)
- Measurements of walking(3，6 months)
- The rate of improvement of BFMDRS score(3，6 months)
- The Beck Depression Inventory(3，6 months)
- Mini-Mental State Examination(3，6 months)