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OpenTrials
Completed

NCT Number: NCT05879939

Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults

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?

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Key information

Age range

19 year–39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Koreans who speak Korean as their mother tongue, aged 19 or older and younger than 40.
  • Those who understood the purpose and procedure of this study and voluntarily participated with consent.

Exclusion criteria

  • - 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.

Treatment and study plan

Transcutaneous, repetitive phrenic nerve electrical stimulation

Procedure

Phrenic nerve electrical stimulation with different stimulation intensity and frequency

Primary outcomes

  1. Phrenic nerve compound muscle action potential (CMAP) amplitude (mV)

    Time frame: Baseline

    ∙ CMAP Amplitude (mV)

  2. ∙ Phrenic nerve compound muscle action potential (CMAP) duration (ms)

    Time frame: Baseline

    ∙ CMAP duration (ms)

  3. ∙ Phrenic nerve compound muscle action potential (CMAP) area (mV∙ms)

    Time frame: Baseline

    ∙ CMAP area (mV∙ms)

Secondary outcomes

  1. Respiratory function

    Time frame: Baseline

    ∙ Maximum inspiratory pressure (MIP)

  2. Diaphragmatic function

    Time frame: Baseline

    ∙ Baseline diaphragm thickness

  3. Diaphragmatic function

    Time frame: Baseline

    ∙ Diaphragm thickening fraction percent: the difference between diaphragm thickness at the end of inspiration (DTi) and at the end of expiration (DTe) divided by DTe × 100

  4. Pain during phrenic stimulation

    Time frame: Baseline

    ∙ Numeric rating scale (range: 0~10): This scale ranges from 0 to 10 points, with higher scores indicating more severe pain.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 30, 2023
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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