Vibrotactile Coordinated Reset for Parkinsons Patients Who Are on Dopaminergic Medication
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- MDS-UPDRS Part 3
研究概览
简要总结
The purpose of this clinical trial is to test the efficacy of vibrotactile coordinated reset stimulation to improve movement ability and other symptoms of human subject participants with Parkinsons Disease who take dopaminergic medication and are unable to withhold this medication. Participants will be followed for five years and make a total of five study visits.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age at the time of enrollment: Adults 18 and older
- •Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 4
- •Fluent in English
- •Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
- •Lives in the United States
排除标准
- •Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies.
- •Any current drug or alcohol abuse.
- •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.
- •Patient is unable to communicate properly with staff (i.e., severe speech problems).
- •Excessive drooling
研究组 & 干预措施
Stimulation
Participants will stimulate with the device, called the Stanford CR glove, on a daily or weekly basis depending on their progress through the study procedures. The device itself is a glove that is designed to deliver vibrations to the fingertips of each hand.
干预措施: Vibrotactile Coordinated Reset (Device)
结局指标
主要结局
MDS-UPDRS Part 3
时间窗: Baseline, 6 months, 12 months, 18 months, 24 months
The Movement Disorder Society Unified Parkinsons Disease Rating Scale Part 3 assessment, obtained while the participant is off medication, is a scale that measures motor ability within Parkinsons patients. For part 3, the scales minimum values are 0 and max value is 132. Higher scores indicate more impaired motor ability, while lower scores indicate less impaired motor ability. A score of 0 indicates no motor impairment.
次要结局
未报告次要终点
研究者
Vivek P. Buch
Assistant Professor of Neurosurgery
Stanford University