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Authors
Prott, Lea S. https://orcid.org/0000-0003-0792-0830
Spitznagel, Frank A.
Hugger, Alfons
Langner, Robert
Gierthmühlen, Petra C.
Gierthmühlen, Mortimer
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Funding
Funding for this research was provided by:
Heinrich-Heine-Universität Düsseldorf
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Article History
Received: 11 May 2023
Accepted: 12 January 2024
First Online: 8 February 2024
Declarations
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: This trial was approved by the Ethics Commission of the University Hospital Düsseldorf (Reference number: 2022–1889) on July 1st, 2022. Accepted version of the study protocol is 1.3.The study was designed according to Good Clinical Practice (GCP), the principles of the Declaration of Helsinki and standards for professional conduct. Participants will be informed in detail before participating in the study and sign an informed consent term. The results of this randomized pilot study will be disseminated via peer-reviewed publications and congress presentations. This present protocol was written based on the Standard Protocol Items for Clinical Trials (SPIRIT).
: MG is founder and advisor of the Neuroloop GmbH. This start-up develops an invasive vagus nerve stimulator against arterial hypertension. The company has no link to this study, and the topic (non-invasive VNS, pain) does not interfere with the company’s focus (invasive VNS, hypertension).
