NCT02370108Unknown1 期
The Study of Rest Tremor Suppression by Using Electrical Muscle Stimulation
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 主要终点
- Number of participant who had tremor suppression determine by reduction of tremor rating scale during electrical muscle stimulation
研究概览
简要总结
This study is aimed to study the safety and feasibility of electrical muscle stimulation (EMS) in suppression of tremor from various causes especially for rest tremor in Parkinson's disease.
详细描述
Study method as follows:
- All subjects will be provided the information on this research study and informed consent will be sought for every subjects.
- All subjects (30 PD patients and 30 others tremor patients) will be interviewed by a movement 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 EMS for suppression of tremor. Physical examinations of each patient will be recorded by the video recording for later reviewed.
- All essential tremor and dystonic tremor patients will be examined by a movement disorders specialist for the tremor severity according to the Fahn, Tolosa, Marin Tremor Rating Scale. Physical examinations of each patient will be recorded by the video recording for later reviewed.
All patient will be determined for feasibility to use EMS and safety of EMS. Pain will determined by visual analog scale.
- All patients will be monitored their hand tremor at resting position and postural position. The tremor analysis with accelerometer and gyroscope system (Parkinson Monitor V0.006 Beta) and the surface EMG (Nicolet EDX Viking) will be conducted. The surface EMG electrode will place over thenar muscle of the hand, which is the most predominant sided of tremor, for quantitative measurement and determination of tremor physiology.
- All participants data from surface EMG will be applied to The Matlab™ program (MathWorks Inc.) in order to modify the qualitative signals into quantitative parameters and performing the high-dimensional feature vectors, and later to determine the different efficacy in pulse amplitude of electrical muscle stimulation on feature vectors.
- The electrical muscle stimulation (Intensity™ Twin Stim® III) will be conducted by placement the 2 self-adhesive electrode (size 1.5 inches * 1.5 inches) over thenar muscle and 1st&2nd interrosseous muscle of the hand, which is the most predominant sided of tremor. The EMS will be stimulated PD patients on the rest position, whereas the other tremors patients in both rest position and postural position. The pulse amplitude will be slowly titration until provided the tetanic muscle contraction (motor threshold) without pain (all applied frequency is 50 Hz).
- All of examination will be taken for 30 minutes for each one subject.
Data Collection
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •For PD patients
- •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 For other tremor patients
- •Adults ≥ 18 years old.
- •Patients with essential tremor diagnosed according to the TRIG criteria for essential tremor or patients with dystonic tremor diagnosed according to the proposed definition in which their symptoms shared similar trait of medically intractable tremor.
- •Informed consent
排除标准
- •For PD patients
- •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.
- •For other tremor patients
- •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.
研究组 & 干预措施
PD patient
Experimental
Parkinson's disease patients will get the electrical muscle stimulation at the most tremulous hand at 50 Hz frequency, maximal tolerate pulse amplitude (not over 20 mA), duration of stimulation for 10 second.
干预措施: electrical muscle stimulation (Device)
OT patients
Experimental
others tremor patients will get the electrical muscle stimulation at the most tremulous hand at 50 Hz frequency, maximal tolerate pulse amplitude (not over 20 mA), duration of stimulation for 10 second.
干预措施: electrical muscle stimulation (Device)
结局指标
主要结局
Number of participant who had tremor suppression determine by reduction of tremor rating scale during electrical muscle stimulation
时间窗: up to 1 month follow up
To determine the number of participant with tremor suppression during electrical muscle stimulation
次要结局
- Number of participant who report pain or any adverse events from electrical muscle stimulation(up to 1 month follow up)
- The severity of pain related from electrical muscle stimulation by visual analog scale(intraoperative)
研究者
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