Study to Optimize and Validate the Treatment Parameters for the Empower Neuromodulation System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced Effective Electrode Placement
研究概览
简要总结
The subject will be administered a treatment at a treatment location and then be asked if he/she believes it is the active treatment, sham treatment, or does not know. A clinical-grade nerve conduction assessment system will be used both to provide electrical stimulation at four locations to record peripheral responses. The subject will self-administer two treatment sessions at two active treatment sites.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is 21-75 years old
- •Can provide informed consent
- •Currently has a stable living situation
- •Had one heavy drinking week (>7 drinks/week for women; >14 drinks/week for men) over the past 6 months
- •Has a breath alcohol concentration of 0.00% at enrollment
- •Is willing to follow all study procedures
排除标准
- •Has been diagnosed with schizophrenia, epilepsy, peripheral neuropathy, or nerve damage
- •Has implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
- •Has a tattoo or conductive, ferromagnetic, or other magnetic-sensitive metals that cannot be removed from the hand, wrist, or biceps
- •Is currently pregnant or breastfeeding
- •Has a bleeding disorder, a history of deep vein thrombosis, or is on anticoagulation drugs
- •Has used an investigational drug/device therapy within the past 4 weeks
- •Is deemed unsuitable for enrollment in study by the PI
研究组 & 干预措施
TENS treatment arm
This study is a usability study, where all subjects will receive the same experimental treatment for their single visit.
干预措施: TENS (Device)
结局指标
主要结局
Number of Participants Who Experienced Effective Electrode Placement
时间窗: 2 hours, length of study visit
Compare two active treatment electrode locations to evaluate the effect of electrode placement on the appearance of sensory nerve action potentials, including tingling sensation, along the stimulated nerve using electromyography (EMG).
次要结局
未报告次要终点