120
Participants
Start Date
November 6, 2023
Primary Completion Date
November 30, 2025
Study Completion Date
December 20, 2025
Vagal stimulation with the device tVNS from tVNS Technologies GmbH
The tVNS device is used to stimulate the Ramus auricularis of the Nervus vagus with a dedicated ear electrode for at least one hour per day on a daily basis. Stimulation frequency is 20Hz, pulsewidth is 200µs and amplitude is determined individually.
Sham stimulation with the device tVNS from tVNS Technologies GmbH
The tVNS device is used to stimulate the Ramus auricularis of the Nervus vagus with a dedicated ear electrode for at least one hour per day on a daily basis. In this case to perform a sham stimulation a non conducting ear electrode is used. The device is set to the same settings with a frequency of 20Hz, a pulsewidth of 200µs and an amplitude that is determined individually.
RECRUITING
Marienhaus Klinikum Hetzelstift, Neustadt
Deutsche Stiftung für Herzforschung
OTHER
Johannes Gutenberg University Mainz
OTHER
Krankenhaus Hetzelstift
OTHER