NCT05879939已完成不适用
Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- ∙ Phrenic nerve compound muscle action potential (CMAP) area (mV∙ms)
研究概览
简要总结
The goal of this observational study is to characterize the standardized stimulation parameter for noninvasive, transcutaneous, repetitive phrenic nerve electrical stimulation.
The main questions it aims to answer are:
- Is the phrenic nerve repetitive electrical stimulation test feasible for use as non-invasive transcutaneous electrical stimulation?
- What is the most optimal stimulation parameters for repetitive phrenic nerve electrical stimulation in healthy adult populations in terms of effective and safe activation of diaphragm?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Koreans who speak Korean as their mother tongue, aged 19 or older and younger than
- •Those who understood the purpose and procedure of this study and voluntarily participated with consent.
排除标准
- •Those who have any neuromuscular disease.
- •Those whom abnormal findings are observed on a neurological examination. e.g.) Cases with abnormal findings in peripheral motor nerve (median nerve) and sensory nerve (sural nerve) conduction studies performed in screening.
- •e.g.) People who have been diagnosed with a neuromuscular junctional diseases such as myasthenia gravis or receiving related treatment.
- •In the case of implantable electronic medical devices such as pacemakers, implantable cardioverter defibrillators (ICDs), and spinal cord stimulation devices.
- •Those who have any history of radiation therapy or chemotherapy for cancer within a year.
- •People who have a history of cardiovascular or cerebrovascular disease or lung disease within 6 months.
- •Those who have been diagnosed with a psychiatric/neurological problem or taking related medications that may affect electrophysiological study.
- •Those who are pregnant or may be pregnant.
- •Those who are judged to lack the cognitive ability to understand the explanation of the purpose and procedure of this study.
- •Those whom the researchers judge for other reasons to be inappropriate to participate in this study.
结局指标
主要结局
∙ Phrenic nerve compound muscle action potential (CMAP) area (mV∙ms)
时间窗: Baseline
∙ CMAP area (mV∙ms)
∙ Phrenic nerve compound muscle action potential (CMAP) duration (ms)
时间窗: Baseline
∙ CMAP duration (ms)
Phrenic nerve compound muscle action potential (CMAP) amplitude (mV)
时间窗: Baseline
∙ CMAP Amplitude (mV)
次要结局
- Pain during phrenic stimulation(Baseline)
- Respiratory function(Baseline)
- Diaphragmatic function(Baseline)
研究者
Sung Eun Hyun
Assistant professor (MD, PhD)
Seoul National University Hospital
研究点 (1)
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