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?

Study Overview

• Status: Completed
• Conditions: Electrical Stimulation; Phrenic Nerve
• Intervention / Treatment: Procedure: Transcutaneous, repetitive phrenic nerve electrical stimulation

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

• Study Contact: Name: Sung Eun Hyun, MD, PhD; Phone Number: +82-2-2072-1529; Email: sechyun@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory function	∙ Maximum inspiratory pressure (MIP)	Baseline
Diaphragmatic function	∙ Baseline diaphragm thickness	Baseline
Diaphragmatic function	∙ 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	Baseline
Pain during phrenic stimulation	∙ Numeric rating scale (range: 0~10): This scale ranges from 0 to 10 points, with higher scores indicating more severe pain.	Baseline

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: National Research Foundation of Korea
• Investigators: Principal Investigator: Sung Eun Hyun, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Actual): July 18, 2023
• Study Completion (Actual): July 18, 2023

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022R1F1A1071488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No