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Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults

Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05879939
Enrollment
12
Registered
2023-05-30
Start date
2023-04-17
Completion date
2023-07-18
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electrical Stimulation, Phrenic Nerve

Brief summary

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?

Interventions

Phrenic nerve electrical stimulation with different stimulation intensity and frequency

Sponsors

National Research Foundation of Korea
CollaboratorOTHER
Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 39 Years
Healthy volunteers
Yes

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

1. \- 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. 2. In the case of implantable electronic medical devices such as pacemakers, implantable cardioverter defibrillators (ICDs), and spinal cord stimulation devices. 3. Those who have any history of radiation therapy or chemotherapy for cancer within a year. 4. People who have a history of cardiovascular or cerebrovascular disease or lung disease within 6 months. 5. Those who have been diagnosed with a psychiatric/neurological problem or taking related medications that may affect electrophysiological study. 6. Those who are pregnant or may be pregnant. 7. Those who are judged to lack the cognitive ability to understand the explanation of the purpose and procedure of this study. 8. Those whom the researchers judge for other reasons to be inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frameDescription
Phrenic nerve compound muscle action potential (CMAP) amplitude (mV)Baseline∙ CMAP Amplitude (mV)
∙ Phrenic nerve compound muscle action potential (CMAP) duration (ms)Baseline∙ CMAP duration (ms)
∙ Phrenic nerve compound muscle action potential (CMAP) area (mV∙ms)Baseline∙ CMAP area (mV∙ms)

Secondary

MeasureTime frameDescription
Respiratory functionBaseline∙ Maximum inspiratory pressure (MIP)
Diaphragmatic functionBaseline∙ Baseline diaphragm thickness
Pain during phrenic stimulationBaseline∙ Numeric rating scale (range: 0\ 10): This scale ranges from 0 to 10 points, with higher scores indicating more severe pain.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026