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临床试验/NCT03320681
NCT03320681已完成不适用

Effect Mechanism of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms

Inventram1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年5月20日最近更新:
适应症
干预措施

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

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

Active Comparator

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

Other

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

研究者

发起方
Inventram
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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