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Authors
Münchenberg, Pauline Sarah http://orcid.org/0000-0002-6184-2995
Schulz, Ricarda Sophia http://orcid.org/0009-0006-9725-7620
Wainwright, Kerstin http://orcid.org/0000-0002-0483-768X
Mayer, Imke http://orcid.org/0000-0003-4936-5062
Holtkamp, Martin http://orcid.org/0000-0003-2258-1670
Meisel, Christian http://orcid.org/0000-0003-2984-5480
Kurth, Tobias http://orcid.org/0000-0001-7169-2620
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Vorderwülbecke, Bernd
Steinbrenner, Mirja
Endres, Matthias
Gorski, Claudia
Prasser, Fabian
Kaindl, Angela
Weschke, Bernhard
Potratz, Cornelia
Fenske, Pascal
von Podewils, Felix
Bertsche, Astrid
Viebahn, Sarah Mai
Gaida, Bernadette
Utzig, Norbert
Schulz, Juliane
Mayer, Thomas
Hopp, Peter
Holert, Nils
Wienecke, Miriam
Leonhardt, Georg
Müller, Peggy
Knobelsdorf, Petra
Wolter, Antke
Klinker, Anne
Brandebusemeyer, Mara
Nussbaum, Uwe
Seemann, Jannis
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Funding
Funding for this research was provided by:
German Innovations Fund of the Federal Joint Committee (01NVF22101, 01NVF22101, 01NVF22101, 01NVF22101, 01NVF22101)
Charité - Universitätsmedizin Berlin
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Article History
Received: 21 February 2024
Accepted: 3 May 2024
First Online: 27 August 2024
Declarations
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: The ALVEEG study was approved by the Ethics Committee of the Charité – Universitätsmedizin Berlin, Berlin, Germany (approval no. EA2/227/23). In case of any changes to the presented study protocol, a re-approval of the Ethics Committee is required. All patients participating in the study will have to provide written informed consent, including the publication of results in peer-reviewed journals. Furthermore, patients and caretakers will receive information on how to handle seizures that might occur during the ALVEEG before the beginning of the study (e.g., )<i>.</i>Data transfer protocols have been monitored by the local data protection officers of the participating institutions and comply with the EU General Data Protection Regulation (GDPR), including the data for the evaluation, which will be anonymized. The analysis of ALVEEG is partially based on claims data. Approval by the supervisory authority of the participating health insurances is needed to release the claims data. ALVEEG will follow the Declaration of Helsinki in its current version, the guidelines of the International Conference on Harmonization of Good Clinical Practice, and applicable national regulations. In case of essential modifications to the current protocol, the funder, all relevant parties of the project, the trial registry, and journals will be informed. After the evaluation of the study data, the results will be reported to all project stakeholders and the funding agency involved by means of a formal report. Additionally, study findings are intended to be published in peer-reviewed scientific journals. Authors and collaborators will be engaged in the composition of manuscripts, press releases, and other formats of publication. It is also envisaged to disseminate the results at conferences and on the project’s website.
: Not applicable.
: During the last three years, MH has received personal fees from Angelini, Bial, Desitin, Eisai, Jazz Pharma, and UCB. Outside of the submitted work, TK reports to have received research grants from the Bundesministerium für Gesundheit (BMG – Federal Ministry of Health, Germany). He further has received personal compensation from Eli Lilly, the BMJ, and Frontiers. All the remaining authors report no competing interests.
