Efficacy Investigation of a Non-invasive Wearable Electrostimulation Device for 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
- 24
- 试验地点
- 2
- 主要终点
- Change in the UPDRS Motor Score (Part III)
研究概览
简要总结
Investigation efficacy of a non-invasive wearable electrostimulator device where the supplementary motor area, premotor area and/or subthalamic nucleus are stimulated bilaterally and extracranially.
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
- 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
Instrinsic auricular muscles will be stimulated for 20 minutes
干预措施: Electro-stimulation (Device)
Placebo
Wearable stimulators will be placed on the patients and controls without stimulation for 20 minutes
干预措施: Placebo (Other)
Sham
An area out of the instrinsic auricular muscles region will be stimulated with the same parameters of the active group for 20 minutes
干预措施: Electro-stimulation (Device)
Passive Control
Only the electrodes of the wearable stimulators will be inserted but there will not be electrostimulation for 20 minutes
结局指标
主要结局
Change in the UPDRS Motor Score (Part III)
时间窗: 30 minutes after the stimulation is terminated.
Evaluation of patients' disease level with UPDRS examination 30 minutes after the stimulation is terminated.
次要结局
- Change in the gait and balance parameters (cadence)(30 minutes after the stimulation is terminated.)
- Change in the gait and balance parameters (Stride length)(30 minutes after the stimulation is terminated.)
- Change in the gait and balance parameters (Stride velocity)(30 minutes after the stimulation is terminated.)
- Change in the gait and balance parameters(30 minutes after the stimulation is terminated.)
研究者
Yasemin Gürsoy Özdemir
Professor
Koç University