Safety and Usability of the Cionic Neural Sleeve for Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Cionic, Inc.
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Number of Participants Able to Independently Exit a Stimulation Program Using the Cionic Neural Sleeve
研究概览
简要总结
This research will investigate the safety and usability of the Cionic Neural Sleeve Multistim System for 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported gait impairment
- •Have access to a smartphone with iOS or Android operating system with Bluetooth capabilities and internet connection
- •Ability to walk with or without an assistive device for up to 1 minute
- •Leg measurements within sizing range of the Cionic Neural Sleeve
排除标准
- •Daily occurrence of falls
- •Implanted demand-type cardiac pacemaker or defibrillator
- •Malignant tumor or existing thrombosis in the leg
- •Fracture or dislocation in the leg that could be adversely affected by motion from stimulation
结局指标
主要结局
Number of Participants Able to Independently Exit a Stimulation Program Using the Cionic Neural Sleeve
时间窗: Day 0, Week 6, Week 12
Participants' ability to independently exit (terminate) an active stimulation program on the Cionic Neural Sleeve will be assessed during study visits. Independence is defined as successful completion of the task without verbal cueing or physical assistance from study staff. Study staff will document whether the participant is able to exit the program independently (yes/no) at each visit.
Number of Participants Able to Independently Test Stimulation Using the Cionic Neural Sleeve
时间窗: Day 0, Week 6, Week 12
Participants' ability to independently initiate and test stimulation on the Cionic Neural Sleeve will be assessed during study visits. Successful task completion is defined as the participant correctly activating stimulation and confirming perception of stimulation without assistance. Study staff will document successful independent testing (yes/no).
Number of Participants Able to Independently Calibrate the Cionic Neural Sleeve System
时间窗: Day 0, Week 6, Week 12
Participants' ability to independently complete device calibration of the Cionic Neural Sleeve system will be assessed during study visits. Calibration is defined as completion of the device-guided calibration procedure without verbal or physical assistance. Study staff will document successful independent calibration (yes/no).
Safety of the Cionic Neural Sleeve
时间窗: Day 0, Week 6, Week 12
To understand the device's safety profile and potential side effects, researchers will record any adverse events during their home use.
次要结局
未报告次要终点
研究者
Rebecca Webster
Clinical Operations Manager
Cionic, Inc.