Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults

Last updated: March 9, 2024
Sponsor: Seoul National University Hospital
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Percutaneous, repetitive phrenic nerve electrical stimulation

Transcutaneous, repetitive phrenic nerve electrical stimulation

Clinical Study ID

NCT05879939
2022R1F1A1071488
  • Ages 19-39
  • All Genders
  • Accepts Healthy Volunteers

Study 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?

Eligibility Criteria

Inclusion

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 voluntarilyparticipated with consent.

Exclusion

Exclusion Criteria:

    • Those who have any neuromuscular disease.
  • Those whom abnormal findings are observed on a neurological examination. e.g.) Caseswith 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 asmyasthenia gravis or receiving related treatment.
  1. In the case of implantable electronic medical devices such as pacemakers, implantablecardioverter defibrillators (ICDs), and spinal cord stimulation devices.
  2. Those who have any history of radiation therapy or chemotherapy for cancer within ayear.
  3. People who have a history of cardiovascular or cerebrovascular disease or lung diseasewithin 6 months.
  4. Those who have been diagnosed with a psychiatric/neurological problem or takingrelated medications that may affect electrophysiological study.
  5. Those who are pregnant or may be pregnant.
  6. Those who are judged to lack the cognitive ability to understand the explanation ofthe purpose and procedure of this study.
  7. Those whom the researchers judge for other reasons to be inappropriate to participatein this study.

Study Design

Total Participants: 12
Treatment Group(s): 2
Primary Treatment: Percutaneous, repetitive phrenic nerve electrical stimulation
Phase:
Study Start date:
April 17, 2023
Estimated Completion Date:
July 18, 2023

Connect with a study center

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

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