Clinical trial NCT05302752: Quantification and Repeatability of Magnetic Stimulation
Official title: Quantification and Repeatability of Responses to Rapid Bilateral Magnetic Stimulation of the Phrenic Nerves
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diaphragm contractility
timeFrame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec
Secondary outcomes:
Other outcomes:
measure: Changes in airflow
timeFrame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
measure: Changes in chest and abdominal movements
timeFrame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
measure: Changes in costal diaphragm activity
timeFrame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
measure: Head, shoulder and arm accelerations
timeFrame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
measure: Body movement
timeFrame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
measure: Changes in skin conductance
timeFrame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
measure: Changes in heart rate
timeFrame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
measure: Changes in blood pressure
timeFrame: Continuously measured from 10 sec before until 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
measure: Perception of pain, paresthesia and discomfort
timeFrame: Assessed 10 sec after each stimulation. One stimulation lasts for approx. 1 sec.
Locations:
city: Zurich
country: Switzerland
facility: Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
state: ZH
Study officials:
affiliation: ETH Zurich, Exercise Physiology Lab, Institute of Human Movement Sciences and Sport
name: Christina M. Spengler, Prof.
role: PRINCIPAL_INVESTIGATOR
References: