Electrical StimulationNCT05879939
Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults
An observational study of Electrical Stimulation and Phrenic Nerve, run by Seoul National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Electrical Stimulation, Phrenic Nerve
- What is being tested?
- Transcutaneous, repetitive phrenic nerve electrical stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Apr 2023to 18 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adult population who have read the recruitment announcement, voluntarily expressed their intention to participate, and have met the eligibility criteria.
Who may be able to join
- 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.
Who cannot join
- - 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.
- In the case of implantable electronic medical devices such as pacemakers, implantable cardioverter defibrillators (ICDs), and spinal cord stimulation devices.
- Those who have any history of radiation therapy or chemotherapy for cancer within a year.
- People who have a history of cardiovascular or cerebrovascular disease or lung disease within 6 months.
Show all 10Show fewer
- Those who have been diagnosed with a psychiatric/neurological problem or taking related medications that may affect electrophysiological study.
- Those who are pregnant or may be pregnant.
- Those who are judged to lack the cognitive ability to understand the explanation of the purpose and procedure of this study.
- Those whom the researchers judge for other reasons to be inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
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?
- Conditions
- Electrical Stimulation, Phrenic Nerve
- Being tested
- Transcutaneous, repetitive phrenic nerve electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous, repetitive phrenic nerve electrical stimulationProcedure or surgery
Phrenic nerve electrical stimulation with different stimulation intensity and frequency
What is being measured
The primary outcome is the main question the study is designed to answer.
Phrenic nerve compound muscle action potential (CMAP) amplitude (mV)
∙ CMAP Amplitude (mV)
Measured: Baseline
∙ Phrenic nerve compound muscle action potential (CMAP) duration (ms)
∙ CMAP duration (ms)
Measured: Baseline
∙ Phrenic nerve compound muscle action potential (CMAP) area (mV∙ms)
∙ CMAP area (mV∙ms)
Measured: Baseline
Secondary outcomes (4)
Respiratory function
∙ Maximum inspiratory pressure (MIP)
Measured: Baseline
Diaphragmatic function
∙ Baseline diaphragm thickness
Measured: 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
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start17 Apr 2023
- Primary completion18 Jul 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrical StimulationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Sung Eun Hyun, Seoul National University Hospital
- Investigators
- Sung Eun Hyun, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879939
- Sponsor's protocol ID
- 2022R1F1A1071488
- Status last verified
- Mar 2024
- First submitted
- 23 Mar 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults
- ClinicalTrials.gov ID
- NCT05879939
- Acronym / sponsor ID
- 2022R1F1A1071488
- Conditions
- Electrical Stimulation, Phrenic Nerve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adult population who have read the recruitment announcement, voluntarily expressed their intention to participate, and have met the eligibility criteria.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- - Those who have any neuromuscular disease.
- e.g.) People who have been diagnosed with a neuromuscular junctional diseases such as myasthenia gravis or receiving related treatment.
- In the case of implantable electronic medical devices such as pacemakers, implantable cardioverter defibrillators (ICDs), and spinal cord stimulation devices.
- Those who have any history of radiation therapy or chemotherapy for cancer within a year.
- People who have a history of cardiovascular or cerebrovascular disease or lung disease within 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous, repetitive phrenic nerve electrical stimulationPhrenic nerve electrical stimulation with different stimulation intensity and frequency | Procedure or surgery | – |
Primary outcome
Phrenic nerve compound muscle action potential (CMAP) amplitude (mV)
Time frame: Baseline
∙ CMAP Amplitude (mV)
∙ Phrenic nerve compound muscle action potential (CMAP) duration (ms)
Time frame: Baseline
∙ CMAP duration (ms)
∙ Phrenic nerve compound muscle action potential (CMAP) area (mV∙ms)
Time frame: Baseline
∙ CMAP area (mV∙ms)
4 secondary outcomes
Respiratory function
Time frame: Baseline
Diaphragmatic function
Time frame: Baseline
Diaphragmatic function
Time frame: Baseline
Pain during phrenic stimulation
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Electrical Stimulation
Not yet recruiting
Usability of the FTEXES Wearable Textile Platform for Functional Electrical Stimulation and EMG
Motor Disorders, Neuromuscular Diseases
Enrolling by invitation
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Enrolling by invitation
Brain Stimulation Paired With Structured Language Learning in Adults
Language Development, Learning
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Eun Hyun, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electrical Stimulation and Phrenic Nerve, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phrenic nerve compound muscle action potential (CMAP) amplitude (mV) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.