Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score
研究概览
简要总结
The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on Parkinson's symptoms. vCR will be administered with a device called the Stanford Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as Levodopa and/or deep brain stimulation. Patients will be followed for 14 months.
详细描述
The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with Parkinson's disease and inform the investigators on whether unilateral stimulation could be as effective as bilateral stimulation at producing clinically significant improvements in symptoms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded for 6 months followed by an unblinding of everyone with the exception of the clinical assessor
入排标准
- 年龄范围
- 18 Years 至 92 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 or older
- •Diagnosed with idiopathic Parkinson's Disease
- •Fluent in English
- •Off-state UPDRS III motor score at least 30, as assessed within the past 6 months before study consent or at Screening Visit.
- •Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form and complete study procedures.
排除标准
- •Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
- •Pregnancy, breast-feeding or wanting to become pregnant
- •Physical limitations unrelated to PD that would affect motor ratings
- •Has implantation of a medical device
- •Sensory abnormalities of the fingertips
结局指标
主要结局
Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score
时间窗: Baseline and month 6
Mean change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score. Minimum score - 0 indicates normal functioning Maximum score - 132 indicated severe impairment Lower scores indicate greater functionality and higher scores indicate severe impairment in functionality.
次要结局
未报告次要终点
研究者
Vivek P. Buch
Assistant Professor of Neurosurgery
Stanford University