A Prospective, Randomized, Staggered-onset, Double Blinded, Sham-Controlled Study to Evaluate Peripheral Vibrotactile Coordinated Reset (CR) Stimulation for Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
研究概览
简要总结
This is a study to evaluate peripheral vibrotactile coordinated reset stimulation for Parkinson's disease seeks to explore the safety and efficacy of an experimental non-invasive method to aid in the symptoms of Parkinson's disease. The purpose of the study is to verify the safety and tolerability of non-painful sensory (tactile) vibratory stimulation delivered to the fingertips of patients with Parkinson's disease.
详细描述
This study aims to evaluate the safety and efficacy of a non-invasive, experimental method to aid in the symptoms of Parkinson's disease. A glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients. Vibrotactile coordinated reset (vCR) will help investigators compare durability and efficacy of the tactile stimulation to current medical therapy. Participants will receive vCR for a minimum of 3 months and a maximum of 13 and motor ability will be recorded. If the results of this study suggest that vibrotactile CR stimulation is safe and effective for the treatment of Parkinson's disease, this non-invasive treatment approach would have a substantial impact on Parkinson's disease.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and older
- •Diagnosis of idiopathic Parkinson's disease.
- •Levodopa responsiveness as defined by at least a 30% reduction in Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor subscale (excluding tremor scores) in the ON vs off medication state.
- •Willing to participate in the vibrotactile stimulation sessions for 2 consecutive days initially and willing to return for follow-up visits
- •Able to provide informed consent.
- •Appropriate social support
排除标准
- •Hoehn and Yahr stage greater than 3 in the on medication state
- •Presence of other forms of non-idiopathic parkinsonism, including but not limited to atypical parkinsonism, medication induced parkinsonism, vascular Parkinsonism
- •Any illness that in the investigator's opinion precludes participation in the study
- •Subjects unable to communicate with the investigator and staff
结局指标
主要结局
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
时间窗: Baseline, 3 months
The MDS-UPDRS III is the sum of 33 scores that evaluate Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicated no symptom is present and a maximum score of 4 indicates the most severe symptom, the total scale range is 0-132, where higher scores indicate more severe symptoms.
次要结局
- Levodopa Equivalent Daily Dose(Baseline, 3 months)
- Electroencephalography (EEG) Sensorimotor Relative Power Activity(Baseline, 3 months)
研究者
Peter Tass, MD, PhD
Professor of Neurosurgery
Stanford University