Neurophysiology of Locomotor Adaptation and Freezing of Gait in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Step length magnitude of adaptation
研究概览
简要总结
Locomotor adaptation will be studied using an established split-belt treadmill paradigm, consisting of baseline (1:1 speed ratio), split-belt adaptation (2:1) and post-adaptation (1:1) walking. Split-belt walking will be performed under DBS ON and DBS OFF conditions, while off-medication.
详细描述
We will test the hypotheses that DBS can facilitate split-belt walking adaptation with DBS ON compared with DBS OFF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
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
- •consensus diagnosis of idiopathic PD by fellowship trained movement disorders neurologists at the Normal Fixel Institute of Neurological Diseases;
- •chronically stable DBS, defined as having had DBS for at least 6 months in duration with optimized DBS settings;
- •Age between 18 - 80 years old per the FDA data sheet for PD DBS;
- •no dementia according to the clinical diagnostic criteria for PD dementia;
- •ambulatory without the use of walking aids, or another person's assistance.
排除标准
- •other previous neurological surgery;
- •suspicion of other neurologic diagnoses such as atypical parkinsonism, or Alzheimer's disease.
研究组 & 干预措施
DBS ON
DBS will be turned on
干预措施: Deep Brain Stimulation (DBS) (Device)
DBS OFF
DBS will be turned off
结局指标
主要结局
Step length magnitude of adaptation
时间窗: 1 hour
The magnitude of adaptation in step length asymmetry is calculated as the mean difference in step length asymmetry between early and late adaptation.
Step length after-effects
时间窗: 1 hour
The after-effect in step length asymmetry is calculated as the mean difference in step length asymmetry between baseline and early post-adaptation.
Step length rate of adaptation
时间窗: 1 hour
The rate of adaptation in step length asymmetry is estimated by fitting an exponential decay function to step length asymmetry over the first 100 strides in adaptation.
次要结局
未报告次要终点