Peripheral Sensory Stimulation of the Hand and Synchronized Deep Breathing in the Treatment of Parkinson's Disease: Assessing Safety and Feasibility
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Use the UPDRS to Evaluate safety and feasibility of device
研究概览
简要总结
Safety and Feasibility of Peripheral Sensory Stimulation of the Hand in the Treatment of Parkinson's Disease
详细描述
This is a prospective, homebased, interventional clinical study in which 8 subjects will be enrolled. Eight (8) subjects who suffer from Parkinson's disease will receive treatment using the NeuroGlove.
Up to 8 subjects enrolled and complete study procedures. There will be a single cohort in the study consisting of the subjects with PD who will receive treatment with NeuroGlove.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject.
- •Men and women ≥18 and <85 years of age.
- •Carry an active diagnosis of PD
- •Suffer from PD symptoms that impact subject's daily activities and quality of life
排除标准
- •Physical limitations of the upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)
- •Lacks the ability to comprehend or follow instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements.
- •Currently participating in another interventional clinical trial (observational clinical trial participation is allowed for study enrollment.)
结局指标
主要结局
Use the UPDRS to Evaluate safety and feasibility of device
时间窗: 4 weeks
Evaluate safety and feasibility of device use on subjects with active symptoms, monitoring motor symptoms and subjects' sense of well-being. The UPDRS - United Parkinson's Disease Rating scale - developed for research and clinical evaluation will be used. The form has a severity scale with ratings from 0-4 with 0 meaning no severity and 4 meaning extreem severity
Use Custom Satisfaction Scale to Rate and severity of adverse events related to the use of the NeuroGlove.
时间窗: 4 weeks
The Satisfaction scale will assess ease of use, satisfaction, feelings of symptom reduction among other questions with a 5 point scale: Strongly Agree, Agree, Neutral, Disagree, and Strongly Disagree
次要结局
未报告次要终点