Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3
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 motor ability within Parkinson's patients. vCR will be administered with a device called the VT Brain 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. This study will include a dedicated sham that will aid in understanding true treatment effects from vCR.
详细描述
Current treatments for Parkinson's disease include medications, surgical measures, or a combination of both. However, long term use of medications can result intolerable side effects, especially at higher doses. If patients under go Deep Brain Stimulation (DBS) surgery, risks include risk of stroke, infection, seizure, hemorrhage or others we may not anticipate. Our investigators hope to confirm a non-invasive method of applying the stimulation by vibrotactile stimulation delivered through the fingertips will alleviate severity in motor symptoms in Parkinson's patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3
时间窗: 14months
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. This evaluation will be done in person at baseline, 3,6 and 7 months. The remote version will be done at 10, 13 and 14 months
次要结局
- Spontaneous electroencephalography (EEG)(7 months)
- Parkinson's disease sleep scale (PDSS)(14 months)
- Vibration-only evoked EEG potentials(7 months)
- PD Quality of Life Questionnaire-39 (PDQ-39)(14 months)
- University of Pennsylvania Smell Identification Test (UPSIT)(7 months)
- Levodopa equivalent daily dose (LEDD)(14 months)
- Sensorimotor task EEG(7 months)
- Vibratory temporal discrimination task (VTDT)(7 months)
- Speech and voice assessments(7 months)
- Kinesia One motor evaluation(14 months)
- Freezing of Gait Questionnaire(14 months)