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临床试验/NCT02370134
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

Chulalongkorn University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年2月最近更新:
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

  1. Target: Thai Parkinson's disease (PD) patients with predominant rest tremor : 50 patients
  2. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roongroj Bhidayasiri

Comprehensive Movement Disorders Center

Chulalongkorn University

研究点 (2)

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