Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults

Electrical Stimulation Clinical Trial

Official title:

Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05879939
• Other study ID #: 2022R1F1A1071488
• Status: Completed
• Start date: April 17, 2023
• Est. completion date: July 18, 2023

Study information

• Verified date: March 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 18, 2023
• Est. primary completion date: July 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Electrical Stimulation

Intervention

Procedure:
• Transcutaneous, repetitive phrenic nerve electrical stimulation
Phrenic nerve electrical stimulation with different stimulation intensity and frequency

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phrenic nerve compound muscle action potential (CMAP) amplitude (mV)	· CMAP Amplitude (mV)	Baseline
Primary	· Phrenic nerve compound muscle action potential (CMAP) duration (ms)	· CMAP duration (ms)	Baseline
Primary	· Phrenic nerve compound muscle action potential (CMAP) area (mV·ms)	· CMAP area (mV·ms)	Baseline
Secondary	Respiratory function	· Maximum inspiratory pressure (MIP)	Baseline
Secondary	Diaphragmatic function	· Baseline diaphragm thickness	Baseline
Secondary	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
Secondary	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