Clinical trial NCT05879939: Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults
Official title: Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Electrical Stimulation
Phrenic Nerve
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2023-05-30
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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?


Eligibility criteria: 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.

Primary outcomes:
measure: Phrenic nerve compound muscle action potential (CMAP) amplitude (mV)
timeFrame: Baseline
measure: ∙ Phrenic nerve compound muscle action potential (CMAP) duration (ms)
timeFrame: Baseline
measure: ∙ Phrenic nerve compound muscle action potential (CMAP) area (mV∙ms)
timeFrame: Baseline
Secondary outcomes:
measure: Respiratory function
timeFrame: Baseline
measure: Diaphragmatic function
timeFrame: Baseline
measure: Diaphragmatic function
timeFrame: Baseline
measure: Pain during phrenic stimulation
timeFrame: Baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sung Eun Hyun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: