The ET and PD Tremor Study - Rainbow Medical Acute Stimulation Evaluation for Tremor Reduction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- The severe adverse events rate within the procedure
研究概览
简要总结
The current study is designed to test the hypothesis that targeted electrical stimulation will result in upper limb tremor reduction in ET and PD patients.
详细描述
This study will evaluate the effect of Rainbow Medical's stimulation procedure methodology that will be applied temporarily to patients suffering of tremor.
This will be evaluated by assessment of reduction of tremor using accelerometer measurements, patient tremor evaluation diary, tremor rating scale, and the Unified Parkinson's Disease Rating Scale (UPRDS) part III.In addition,tasks for patient with tremor will be conducted before during and after the treatment. The above measurements will provide data on the stimulation procedure effect as compared to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Able to Sign written informed consent in Hebrew.
- •Patient agrees to attend all treatment procedures and follow-up evaluations and is willing and able to comply with all study requirements.
- •Patient with a clinical diagnosis of idiopathic PD, or ET for more than 3 years.
- •Significant tremor for at least one upper limb causing distress or disability.
- •Patient should be stable on anti-Parkinson's disease or anti-tremor medication for at least one month prior to study enrollment.
排除标准
- •Previous participation in another study with any investigational drug or device within the past 90 days.
- •Any active implant (cardiac or other).
- •Current pregnancy or attempting to get pregnant (female patient).
- •Patient has any major illness or medical condition that in the opinion of the physician would interfere with participation in the study.
- •Patient with other significant neurological or psychiatric disease other than Parkinson Disease or Essential Tremor.
- •Patient has any other condition expect for PD and ET that induce tremor.
- •Patient is treated with drug that may induce tremor.
- •Patient abuses drugs or alcohol.
- •Any previous thalamotomy, pallidotomy or patient who has undergone a DBS procedure.
- •Any anticipated need for surgery during the study.
- •Any malignancy in the past 2 years.
- •Patient has confirmation of diagnosis of a terminal illness associated with survival <12 months.
研究组 & 干预措施
Stimulation procedure
Stimulation procedure
干预措施: Stimulation procedure (Procedure)
结局指标
主要结局
The severe adverse events rate within the procedure
时间窗: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
次要结局
- Improvement in tremor symptoms during the procedure(participants will be followed for the duration of hospital stay, an expected average of 3 weeks)