Effect Mechanism of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- fMRI - STN, PPN and cortical connectivity alterations
研究概览
简要总结
Effect Mechanism Investigation of a Wearable Electrostimulator for Rapid Alleviation of Parkinson's Disease Symptoms
详细描述
Activation levels of interested regions of the brain will be measured through fMRI technique prior and after the dry needling and active stimulation applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's Disease
- •H&Y Stage >= 2
- •Existing bradykinesia symptoms
- •Existence of one of the symptoms below
- •Resting Tremor
- •Walking disorder
排除标准
- •Cardiac Pacemaker
- •Psychiatric diagnosis
- •Irregular heart/respiration rate
- •Pregnancy
- •Alcohol consumption
- •Cardiovascular disease history
- •Wearing an electro-active prosthesis
- •Brain surgery history
- •Ongoing TENS/PENS therapy-
研究组 & 干预措施
Active Stimulation
Acupuncture needles will be inserted into the auricular zones and electrical stimulation will be given for 20 minutes.
干预措施: Electrical Stimulation (Device)
Dry Needling
Acupuncture needles will be inserted into the auricular zones for 20 minutes. However, no electrical stimulation will be given
干预措施: Dry Needling Stimulation (Other)
结局指标
主要结局
fMRI - STN, PPN and cortical connectivity alterations
时间窗: Baseline and PostStim (right after the stimulation is terminated)
fMRI - Activation level comparison of the motor and supplementary cortex
时间窗: Baseline and PostStim (right after the stimulation is terminated)
fMRI - Activation level comparison of the subthalamic nucleus (STN) and basal ganglia including pedunculopontine nucleus (PPN)
时间窗: Baseline and PostStim (right after the stimulation is terminated)
次要结局
未报告次要终点
