A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 10
- 主要终点
- Improvement in neck postures/movements
研究概览
简要总结
The purposes of this study are:
- to determine if bilateral pallidal deep brain stimulation results in improvement in neck postures/movements;
- to determine if bilateral pallidal deep brain stimulation results in improvement in quality of life; and
- to document the adverse effects of surgery in patients with cervical dystonia.
详细描述
Deep brain stimulation (DBS) of the globus pallidus has been proposed as a treatment for cervical dystonia. At present there are only anecdotal reports of benefit. The objective of this project is to prospectively assess the outcomes of DBS on cervical dystonia in a blinded manner. Our hypothesis is that in patients refractory to medical management, bilateral pallidal DBS will reduce the severity of cervical dystonia at 1 year follow up.
The research plan is that of a feasibility study, examining outcomes of 10 patients who would be referred for surgical management due to the severity of their disease. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) will be preformed by a blinded neurologist at the completion of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 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
结局指标
主要结局
Improvement in neck postures/movements
Improvement in quality of life
次要结局
- Document adverse effects of surgery