Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults

NCT05879939 | Completed

• 1 other identifier: 2022R1F1A1071488
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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?

Conditions

Electrical Stimulation; Phrenic Nerve

Outcome Measures

Primary Outcomes (3)

• Phrenic nerve compound muscle action potential (CMAP) amplitude (mV)

  ∙ CMAP Amplitude (mV)

  Baseline

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

  ∙ CMAP duration (ms)

  Baseline

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

  ∙ CMAP area (mV∙ms)

  Baseline

Secondary Outcomes (4)

• Respiratory function

  Baseline

• Diaphragmatic function

  Baseline

• Diaphragmatic function

  Baseline

• Pain during phrenic stimulation

  Baseline

Interventions

Transcutaneous, repetitive phrenic nerve electrical stimulation PROCEDURE

Phrenic nerve electrical stimulation with different stimulation intensity and frequency

Eligibility Criteria

• Age: 19 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy adult population who have read the recruitment announcement, voluntarily expressed their intention to participate, and have met the eligibility criteria.

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Officials

• Sung Eun Hyun, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor (MD, PhD)

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: May 30, 2023
• Study Start: April 17, 2023
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

KR (1)