Quantification and Repeatability of Magnetic Stimulation

NCT05302752 | Active Not Recruiting

• 1 other identifier: REMEX-WP1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

In this project the quantification and the repeatability of responses to rapid bilateral magnetic stimulation of the phrenic nerves will be investigated in healthy humans.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Diaphragm contractility

  Transdiaphragmatic pressure changes, i.e. changes in esophageal and gastric pressures, will be measured by a pressure transducer connected to balloon-catheters.

  Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec

Other Outcomes (9)

• Changes in airflow

  Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.

• Changes in chest and abdominal movements

  Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.

• Changes in costal diaphragm activity

  Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.

Study Arms (1)

Bilateral rapid magnetic stimulation of the phrenic nerves

EXPERIMENTAL

Each participant will be tested on three different days with optimal settings for bilateral rapid magnetic stimulation of the phrenic nerves established on visit 1 and then repeated on visits 2 and 3.

Other: Magnetic phrenic nerve stimulation

Interventions

Magnetic phrenic nerve stimulation OTHER

The intervention consists of bilateral rapid magnetic phrenic nerve stimulation on the neck using different stimulation intensities. On one visit, the effect of increasing chest wall stiffness and respiratory muscle work by adding incrementally small weights to the chest/abdomen will be investigated.

Bilateral rapid magnetic stimulation of the phrenic nerves

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy
• non-smoking
• normal lung function
• body mass index: 18.5-29.9 kg/m2
• able to communicate in english
• willing to adhere to study rules

You may not qualify if:

• acute illness or chronic conditions of the gastrointestinal tract, and health conditions affecting metabolism, the cardiovascular or the respiratory system, or sleep
• intake of medications affecting metabolism, the cardiovascular, the neuromuscular or the respiratory system, or sleep
• any metal or electronics inside of the body
• presence of cardiac pacemaker, implanted defibrillators or implanted neurostimulators
• history of seizures or epilepsy
• tatoos on the stimulation sites
• previous enrolment in this study
• for women: pregnancy, breastfeeding, or intention to become pregnant during the study

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich

Zurich, Canton of Zurich, 8092, Switzerland

Location

Study Officials

• Christina M. Spengler, Prof.

  ETH Zurich, Exercise Physiology Lab, Institute of Human Movement Sciences and Sport

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 31, 2022
• Study Start: July 13, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)