Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults

Seoul National University Hospital1 site in 1 country12 target enrollmentApril 17, 2023

ConditionsElectrical Stimulation Phrenic Nerve

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Electrical Stimulation
Sponsor: Seoul National University Hospital
Enrollment: 12
Locations: 1
Primary Endpoint: ∙ Phrenic nerve compound muscle action potential (CMAP) area (mV∙ms)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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?

Registry

clinicaltrials.gov

Start Date

April 17, 2023

End Date

July 18, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Sung Eun Hyun

Assistant professor (MD, PhD)

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

•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.

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.