Back to overview
SNCTP000003536 | NCT04176744 | BASEC2019-01990

Optimierung nicht-invasiver Zwerchfell-Aktivierung mittels magnetischer Stimulation der Phrenikusnerven

Data source: BASEC (Imported from 29.03.2024), WHO (Imported from 29.03.2024)
Changed: Dec 23, 2023, 4:32 PM
Disease category: Other

Brief description of trial (Data source: BASEC)

Bei 12 gesunden Männern und Frauen werden die Zwerchfellnerven im Rahmen von drei Laborbesuchen systematisch mit variierender Stimulationsfrequenz, -intensität und -spule am Hals und im oberen Brustbereich stimuliert. Bei einem der Laborbesuche wird als Vergleich separat auch der Oberschenkelmuskel stimuliert. Ziel dieser Studie ist die Bestimmung des effektivsten Protokolls zur nicht-invasiven Aktivierung des Zwerchfells mittels wiederholter magnetischer Stimulation der Phrenikusnerven.

Health conditions investigated(Data source: BASEC)

Es gibt medizinische Situationen - wie z.B. künstliche Beatmung über mehrere Tage – durch welche Kraft und Funktion des Hauptatmungsmuskels, d.h. des Zwerchfells, reduziert werden kann, was eine längere Entwöhnungsphase vom Beatmungsgerät, eine reduzierte Lebensqualität und Erholungsprognose von Patienten bewirken kann. Um diesem Funktionsverlust entgegenzuwirken, wollen wir mit dieser Studie in einem ersten Schritt herausfinden, mit Protokoll das Zwerchfell am besten nicht-invasiv, mittels magnetischer Stimulation der Phrenikusnerven aktiviert werden kann.

Health conditions (Data source: WHO)

Healthy

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

In dieser Untersuchung wird direkt keine medizinische Intervention untersucht.

Interventions (Data source: WHO)

Other: Uni- and bilateral magnetic phrenic nerve stimulation

Criteria for participation in trial (Data source: BASEC)

Gesund, 18-35 Jahre alt, normalgewichtig

Exclusion criteria (Data source: BASEC)

Akute oder chronische Erkrankungen, bekannte Epilepsie und/oder epileptische
Anfälle in der Vergangenzeit, Metall und/oder Elektronik innerhalb des Körpers

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

- Informed Consent as documented by signature

- Age: 18 - 35 years

- Non-smoking

- Healthy

- Able to communicate in English

- Normal lung function

- Normal Body mass index between 18.5 and 24.9 kg/m2

- Willingness to adhere to the study rules

Exclusion Criteria:

- Acute illness or chronic conditions affecting sleep or the performance of the
respiratory, cardiovascular, neuromuscular, gastrointestinal or muscle system

- Women who are pregnant or breast feeding or have the intention to become pregnant
during the course of the study

- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the participant

- Known or suspected non-compliance, drug or alcohol abuse

- Intake of medication affecting sleep or the performance of the respiratory,
cardiovascular or neuromuscular system or gastrointestinal or muscle system

- Presence of cardiac pacemaker, implanted defibrillators or implanted neurostimulators

- Any metal or electronics inside of the body

- History of seizures or epilepsy

- Tattoos on the stimulation sites

- Previous enrolment into the current study

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT04176744

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04176744
Further information on trial

Date trial registered

Nov 19, 2019

Incorporation of the first participant

Dec 9, 2019

Recruitment status

Completed

Academic title (Data source: WHO)

Optimization of Non-invasive Diaphragm Activation Using Magnetic Phrenic Nerve Stimulation

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).

Phase (Data source: WHO)

N/A

Primary end point (Data source: WHO)

Changes in airflow;Changes in costal diaphragm activity;Changes in abdominal movements;Changes in mouth pressure;Changes in transdiaphragmatic pressure

Secundary end point (Data source: WHO)

Perception of pain, paresthesia and distress;Changes in stress related parameters (heart rate, blood pressure, skin conductance);Changes in head, shoulder and arm movements;Changes in extradiaphragmatic muscle activity

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

No

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Zurich

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Prof. Dr. Christina M. Spengler
+41 44 635 50 07
christina.spengler@hest.ethz.ch

Contact for general information (Data source: WHO)

Christina M. Spengler, Prof.
Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich

Contact for scientific information (Data source: WHO)

Christina M. Spengler, Prof.
Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Date of authorisation by the ethics committee

18.11.2019

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2019-01990

Secondary ID (Data source: WHO)

OPTISTIM_2019
Back to overview