Quantification and Repeatability of Magnetic Stimulation

Quantification and Repeatability of Responses to Rapid Bilateral Magnetic Stimulation of the Phrenic Nerves

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Magnetic phrenic nerve stimulation

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina M. Spengler, Prof.; Phone Number: +41 44 635 5007; Email: christina.spengler@hest.ethz.ch
• Study Contact Backup: Name: Philipp A. Eichenberger, Dr.; Phone Number: +41 44 632 5005; Email: philipp.eichenberger@hest.ethz.ch

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8092
      • Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilateral rapid magnetic stimulation of the phrenic nerves; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in airflow	Flow will be recorded by a pneumotachometer and averaged over breaths.	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	Chest and abdominal movements will be assessed using respiratory belt strain transducers.	Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Changes in costal diaphragm activity	Costal diaphragm activity will be continuously recorded via a wireless surface electromyography system.	Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Head, shoulder and arm accelerations	Head, shoulder and arm movements will be recorded using wireless acceleration sensors attached to the head and arms.	Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Body movement	Overall body movement incl. head, shoulder and arm movements will be recorded using a video camera.	Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Changes in skin conductance	Skin conductance (μS) will be continuously recorded with electrodes worn on two fingers.	Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Changes in heart rate	Heart rate will will be continuously recorded beat by beat (1/min) with electrodes on both wrists and one ankle.	Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Changes in blood pressure	Systolic and diastolic blood pressure (mmHg) will be continuously recorded using a non-invasive device.	Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Perception of pain, paresthesia and discomfort	Participant subject perception of pain, paresthesia and discomfort will be evaluated with 0-to-10-point scale, with 0 = no pain/paresthesia/discomfort and 10 = maximal pain/paresthesia/discomfort. Higher values indicate more perception of the specified sensations.	Assessed 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Investigators: Principal Investigator: Christina M. Spengler, Prof., ETH Zurich, Exercise Physiology Lab, Institute of Human Movement Sciences and Sport

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: REMEX-WP1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No