Quantification and Repeatability of Magnetic Stimulation

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05302752
• Other study ID #: REMEX-WP1
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 13, 2022
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Primary	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