Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia
试验速览
- 阶段
- 1 期
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Burke Fahn Marsden Disability Rating Scale (BFMDRS)
研究概览
简要总结
Dystonia is increasingly being considered as a multi-nodal network disorder involving both basal ganglia and cerebellar dysfunction. The aim of this study is to determine if "Multi-Target" Thalamic and Pallidal Deep Brain Stimulation improves hemi-dystonia patients who are receiving inadequate therapy from GPi DBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with hemi-dystonia secondary to stroke
- •Candidate for GPi DBS
- •Able to provide informed consent
排除标准
- •History of intracranial pathology (such as multiple sclerosis, tumors, or aneurysms) that may account for dystonia or essential tremor.
- •History or evidence of ongoing psychiatric or neurodegenerative disorders (such as Parkinson's disease, Alzheimer's disease).
- •Incompetent adults or those unable to communicate.
研究组 & 干预措施
Pallidal (GPi) Deep Brain Stimulation
GPi is the standard target for treating most dystonia. This setting will be the active comparator
干预措施: Deep Brain Stimulation (Device)
Thalamic (Vim) Deep Brain Stimulation
Vim is the standard target to treat cerebellar dysfunction in movement disorders. It is not routinely used in secondary dystonia
干预措施: Deep Brain Stimulation (Device)
GPi + Vim (Multi-Target) Deep Brain Stimulation
Combined stimulation of GPi and Vim stimulation (both electrodes ON)
干预措施: Deep Brain Stimulation (Device)
结局指标
主要结局
Burke Fahn Marsden Disability Rating Scale (BFMDRS)
时间窗: 3 months
Adverse effects of Vim or Vim + GPi Neuromodulation
时间窗: 3 months
SF-36 Quality of Life Scale
时间窗: 3 months
次要结局
未报告次要终点
研究者
Christopher Honey
Principal Investigator
University of British Columbia