Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults

NCT ID: NCT05879939

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-17

Study Completion Date

2023-07-18

Brief Summary

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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?

Detailed Description

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Conditions

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Electrical Stimulation Phrenic Nerve

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Transcutaneous, repetitive phrenic nerve electrical stimulation

Phrenic nerve electrical stimulation with different stimulation intensity and frequency

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Foundation of Korea

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sung Eun Hyun

Assistant professor (MD, PhD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sung Eun Hyun, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2022R1F1A1071488

Identifier Type: -

Identifier Source: org_study_id

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