Exploit the Neural Source and the Feasibility of Transcranial Direct Current Stimulation for Freezing of Gait in Parkinson's Disease and Multiple System Atrophy
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- EEG recording before and after the tDCS session
研究概览
简要总结
In this project, the investigators will deliver a 5-day session of transcranial direct current stimulation (tDCS) to the leg motor cortex of the FOG patients to examine whether the intervention will benefit the patients in a double blind randomized design. Six assessments with different combinations of clinical scaling, gait analysis, electrophysiological investigation and fMRI examinations before and after tDCS will be conducted. The treatment and placebo groups will be crossed over after one-month washout. The investigators will investigate whether the possible tDCS beneficial effect will be different or similar in patients with different electric sources. In addition, how long the possible beneficial effect of tDCS can be consolidated after the 5-day course of stimulation is also crucial. The investigators aim to peep the myth of FOG in PD and MSA by the multi-modality approach and hope the study will benefit the long suffering patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients meet the diagnosis of PD41 or MSA43 based on the established consensus criteria
- •Age above 30 years old and below 85 years
排除标准
- •Impairment of cognition that leads unable to fully cooperate with the oral commands during examinations
- •Functional III or above congestive heart failure, or cancer with distant metastasis
- •Hoehn and Yahr stage 5 in PD or MSA
研究组 & 干预措施
real tDCS
In transcranial direct current stimulation, the anodal pad was tapped over the primary motor cortex and the cathode pad was adhered of the contralateral frontal region. A constant current of 2.0 mA will be apply for up to 20 mins.
干预措施: Transcranial direct current stimulation (Device)
sham tDCS
In transcranial direct current stimulation, the sham stimulation will be 30s stimulation with ramp up and ramp off for 10s at 2.0 mA.
干预措施: Transcranial direct current stimulation (Device)
结局指标
主要结局
EEG recording before and after the tDCS session
时间窗: baseline to week 4
Gait recording by 64 channels EEG device. Four different frequency bands ( theta, alpha, beta, and gamma) will be investigated. Variables in gait analysis: 1.Gait initiation, 2.Level walking, 3.Gait termination.
次要结局
- Electromyography recording before and after the tDCS session(baseline to week 4)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III before and after the tDCS session(baseline to week 4)
- Change in Unified Multiple System Atrophy Rating Scale (UMSARS) subscores (UMSARS-1 and UMSARS-2) before and after the tDCS session(baseline to week 4)
研究者
Chon-Haw Tsai
The chief, Department of Neurology
China Medical University Hospital