Transcutaneous Repetitive Phrenic Nerve Stimulation in He... | NCT05879939

Studies
Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults

NCT05879939

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Mar 12, 2024Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Electrical Stimulation
Phrenic Nerve

Interventions

Transcutaneous, repetitive phrenic nerve electrical stimulation

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 17, 2023Actual

Primary Completion Date

Jul 18, 2023Actual

Completion Date

Jul 18, 2023Actual

First Submitted Date

Mar 23, 2023

First Submission Date that Met QC Criteria

May 24, 2023

First Posted Date

May 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2024

Last Update Posted Date

Mar 12, 2024Actual

Name	Class
National Research Foundation of Korea	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Name	Type	Description	Arm Group Labels	Other Names
Transcutaneous, repetitive phrenic nerve electrical stimulation	Procedure	Phrenic nerve electrical stimulation with different stimulation intensity and frequency

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phrenic nerve compound muscle action potential (CMAP) amplitude (mV)	∙ CMAP Amplitude (mV)	Baseline
∙ Phrenic nerve compound muscle action potential (CMAP) duration (ms)	∙ CMAP duration (ms)	Baseline
∙ Phrenic nerve compound muscle action potential (CMAP) area (mV∙ms)	∙ CMAP area (mV∙ms)	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Respiratory function	∙ Maximum inspiratory pressure (MIP)	Baseline
Diaphragmatic function	∙ Baseline diaphragm thickness	Baseline

Other Outcomes

Not provided

Eligibility Module

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:

- 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.
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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Healthy adult population who have read the recruitment announcement, voluntarily expressed their intention to participate, and have met the eligibility criteria.

Sampling Method

Probability Sample