NCT02370134Unknown1 期
Development of Parkinson's Glove for Detection and Suppression of Hand Tremor at Rest Among the Tremor-predominant Parkinson's Disease Patients With Medically Intractable Tremor
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of participants who demonstrate the tremor suppression after use parkinson's glove
研究概览
简要总结
This study is aimed to study the feasibility and safety of parkinson's glove that combined 2 module of tremor detection and tremor suppression with electrical muscle stimulation for using as device for rest tremor suppression in parkinson's disease patients
详细描述
Study Population
- Target: Thai Parkinson's disease (PD) patients with predominant rest tremor : 50 patients
- Population sample: Patients who are getting their treatment at the Chulalongkorn Comprehensive Movement Disorder Clinic at King Chulalongkorn Memorial Hospital.
Study methods as follows:
- All PD subjects will be provided the information on this research study and informed consent will be sought for every subjects.
- All PD subjects will be interviewed by a movememt disorders specialist or a trained interviewer for their demographic and clinical data.
- All PD patients will be examined for the severity of Parkinson's disease by a movement disorders specialist according the Unified Parkinson's disease Rating Scale (UPDRS), Hoehn and Yahr score, and tremor rating scale during the 'on period' in order to determine the additional effect of parkinson's glove and sham glove for suppression of tremor
- All PD patients will be randomly allocated into 2 groups (25 Parkinson's glove and 25 sham glove) with block randomization method.
- All patients will get Parkinson's glove for home-based usage for 14 days, the appointment for follow -up will be done for 4 times, with once daily phone call from investigators in order to check for improvement symptoms and all adverse events such as pain will be recorded and determined it severity by the visual analog scale.
Data collection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Adults ≥ 18 years old.
- •Patients with Parkinson's disease diagnosed according to the UKPDSBB criteria with predominantly feature of rest tremor that intractable to medically treatment.
- •Informed consent
排除标准
- •Patients with a history of cardiac arrhythmia, renal failure, hepatic failure, and pregnancy as well as those who had history of seizure or had the risk for tended to become seizure such as those who had focal brain lesions, encephalitis, and stroke patients.
- •Patients with a history of hand surgery and implanted screws or wires in hand area that supposed to place a surface EMG or EMS, as well as those patients who were implanted for electrical devices such as cardiac pacemaker, pulse generator of deep brain stimulation,and intrathecal baclofen pump.
- •Patients who cannot avoid the medication that may potentiate or attenuate tremor such as antihistamines, benzodiazepine, illicit drugs, and thyroid hormone supplement.
结局指标
主要结局
Number of participants who demonstrate the tremor suppression after use parkinson's glove
时间窗: up to 1 month follow up period
To determine the tremor suppression after use the parkinson's glove by the tremor rating scale
次要结局
- Number of Participants who report pain or any adverse events from parkinson's glove(14 days periods of using parkinson's glove and in subsequent 1 month follow up period)
- Determine the severity of pain related with parkinson's glove(14 days periods of using parkinson's glove)
研究者
Roongroj Bhidayasiri
Comprehensive Movement Disorders Center
Chulalongkorn University
研究点 (2)
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