Vibrotactile Coordinated Reset for the Treatment of Post Surgery Refractory Parkinson's Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) change from baseline to 24 months.
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 refractory post-surgery PD. 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 two years.
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
- 35 Years 至 92 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at the time of enrollment: 35 - 92 years
- •Diagnosis of idiopathic Parkinson's disease
- •Surgical treatment for Parkinson's disease that does not involve Deep Brain Stimulation
- •Fluent in English
- •Appropriate social support if required during an off state.
- •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
- •Sensory abnormalities of the fingertips
- •Deep Brain Stimulation treatment
- •PD symptoms so severe and that the patient is bed-bound
结局指标
主要结局
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) change from baseline to 24 months.
时间窗: 24 months
This scale measures motor ability within Parkinson's patients. For part 3, the scales minimum values is 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
- Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change from baseline to 24 months.(24 months)
- Parkinson's Disease-Cognitive Rating Scale (PDCRS) change from baseline to 24 months.(24 months)
- Levodopa equivalent daily dose (LEDD) change from baseline to 24 months(24 months)
- Communicative Participation Item Bank (CPIB; Short Form) change from baseline to 24 months.(24 months)
- Freezing of gait questionnaire (FOG) change from baseline to 24 months(24 months)
- Voice Handicap Index (VHI-10) change from baseline to 24 months(24 months)
- Parkinson's disease cognitive functional rating scale (PD-CFRS) change from baseline to 24 months.(24 months)
- Vibratory temporal discrimination task (VTDT) change from baseline to 24 months.(24 months)
- Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change from baseline to 24 months.(24 months)
- Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2 change from baseline to 24 months.(24 months)
- Parkinsons disease quality of life questionnaire-39 (PDQ-39) change from baseline to 24 months(24 months)
研究者
Peter Tass, MD, PhD
Protocol Director
Stanford University