NCT02263417已完成4 期
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Dystonia
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Burke-Fahn-Marsden Scale (BFM)
研究概览
简要总结
The purpose of this study was to compare the subthalamic nucleus(STN) with the globus pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically refractory dystonia.
详细描述
In this prospective randomized controlled study,elecrodes were bilaterally implanted in STN and Gpi of 40 patients with dystonia.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is aged 18 to 75 years old, male or female.
- •Diagnosed with cervical dystonia by a movement disorders neurologist.
- •Has cervical dystonia alone, not generalized or multifocal.
- •Has had adequate trials of medical therapy.
排除标准
- •Cognitive impairment.
- •Abnormalities on pre-operative magnetic resonance imaging (MRI).
- •Medical conditions precluding general anaesthetic or surgery.
- •Unstable psychiatric disease.
- •Previous brain lesions to treat cervical dystonia.
- •Attended some other trials within three month.
结局指标
主要结局
Burke-Fahn-Marsden Scale (BFM)
时间窗: Change from baseline in BMF at 1, 3 months and 6 months
次要结局
- Quality of life (SF-36)(Change from baseline in SF-36 at 1, 3 months and 6 months)
- Psychiatric assessment (HADS-D and PANSS)(Change from baseline in HADS-D and PANSS at 1, 3 months and 6 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Efficacy and Safety of DBS in Patients With Primary DystoniaDystoniaNCT03017586Beijing Pins Medical Co., Ltd72
已完成
不适用
Follow Up Study for Treatment of Parkinson's Disease With Subthalamic Deep Brain StimulationParkinson DiseaseNCT03230331Ruijin Hospital20
已完成
3 期
Phase I Deep Brain Stimulation (DBS) vs. Best Medical Therapy (BMT) TrialParkinson's DiseaseNCT00056563US Department of Veterans Affairs255
已完成
3 期
STN-Stimulation Versus Best Medical Treatment in Advanced PDParkinson's DiseaseNCT00196911German Parkinson Study Group (GPS)156
已完成
不适用
Effect of Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's DiseaseParkinson's Disease (Disorder)NCT04608123University Hospital, Grenoble31