ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease Phase I
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- PD motor scores measured by Kinesia HomeView
研究概览
简要总结
The purpose of this study is to evaluate the effects of transcranial direct current stimulation (tDCS) on patients with Parkinson's disease during sleep.
详细描述
The clinical study will follow a counterbalanced crossover design during which subjects will undergo two separate pairs of two-consecutive-overnight sleep studies and receive anodal tDCS (active or sham) to M1. The first sleep study in each pair will acclimate subjects to the sleep laboratory and minimize "first night" effects, thus no tDCS will be applied. The second sleep study in each pair will include active or sham tDCS, presented in a pseudorandom order such that approximately half of the subjects receive active tDCS first while the other half receives sham first. The two pairs of sleep studies will be separated by one to three weeks.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of idiopathic Parkinson's disease (PD) according to the UK PD brain bank criteria
- •Hoehn and Yahr stage II-III when off anti-parkinsonian medication
- •Able to provide informed consent
- •Currently taking levodopa (300-800 mg per day)
- •On stable regimen of anti-parkinsonian medication for at least one month before study entry and able to continue on a stable regimen for the duration of the study
- •Presence of early morning akinesia
- •Naïve to tDCS.
排除标准
- •Children will be excluded from this study due to the fact that they are unlikely to have PD
- •Significant medical or psychiatric illness, significant neurological disease other than PD, metal objects and/or deep brain stimulators in the head that might pose a hazard during tDCS
- •Dementia, as evidenced by a score less than 26 on the Montreal Cognitive Assessment
- •Significant depression (Geriatric Depression Scale score < 20)
- •Presence of hallucinations
- •Having undergone any surgical procedure for treatment of PD including deep brain stimulation (DBS), pallidotomy, thalamotomy, or other brain surgeries
- •A history of seizures
- •A known history of severe sleep apnea or sleep onset insomnia
- •Skin diseases that could potentially cause irritations under electrodes
结局指标
主要结局
PD motor scores measured by Kinesia HomeView
时间窗: Average change from two days before tDCS sleep study to two days after tDCS sleep study
PD motor symptoms will be assessed for two days before (baseline) and two days after each tDCS sleep study using Kinesia HomeView. Changes for active tDCS will be compared to changes for sham tDCS.
次要结局
- Overnight Polysomnography(During each sleep study)
- tDCS sensations(Day after tDCS sleep studies)
- Sleepiness(Average change from two days before tDCS sleep study to two days after tDCS sleep study)
- Motor scores measured by the Unified Parkinson's Disease Rating Scale(Average change from day before tDCS sleep study to day after tDCS sleep study)