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Authors
Schulz, Ricarda Sophia https://orcid.org/0009-0006-9725-7620
Münchenberg, Pauline Sarah https://orcid.org/0000-0002-6184-2995
Thomas, Carmen https://orcid.org/0009-0001-1444-5161
Dorison, Alice Charlotte https://orcid.org/0009-0009-6119-1801
Wischmann, Hans-Aloys https://orcid.org/0009-0000-1201-343X
Gonçalves, Ana Sofia Oliveira https://orcid.org/0000-0002-5678-4137
Mayer, Imke https://orcid.org/0000-0003-4936-5062
Wainwright, Kerstin https://orcid.org/0000-0002-0483-768X
Holtkamp, Martin https://orcid.org/0000-0003-2258-1670
Meisel, Christian https://orcid.org/0000-0003-2984-5480
Kurth, Tobias https://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:
Charité - Universitätsmedizin Berlin
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Article History
Received: 27 August 2024
Accepted: 11 April 2025
First Online: 18 April 2025
Declarations
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: The Ethics Committee of the Charité – Universitätsmedizin Berlin, Berlin, Germany (approval no. EA2/227/23) validated and approved the ALVEEG study. Any changes to the submitted study protocol will require a re-approval by the Ethics Committee. Written informed consent, including publication of results in peer-reviewed journals, must be obtained from all patients enrolled in the study. Patients and caretakers will also receive information on how to manage seizures that might occur during the intervention (ALVEEG) prior to the start of the study (e.g., ).Local data protection officers of the participating institutions have monitored and confirmed the data transfer protocols, which comply with the EU General Data Protection Regulation (GDPR), including the evaluation data, which will be anonymized. ALVEEG’s analysis is based in part on claims data. To release the claims data, approval by the supervisory authority of the participating health insurances is necessary. ALVEEG will follow the latest version of the Declaration of Helsinki, the guidelines of the International Conference on Harmonization of Good Clinical Practice, and applicable national regulations. The funder, all relevant parties of the project, the trial registry, and journals will be informed in case of substantial changes to the current protocol. All project stakeholders and the funding agency involved will be notified of the trial results by means of a formal report after the evaluation of the study data. Further, study findings are intended to be published in peer-reviewed scientific journals. Authors and collaborators will be involved in writing manuscripts, press releases, and other publication formats. Additionally, the results will be distributed at conferences and on the project’s website.
: Not applicable.
: RS, PM, CT, AD, KW, HW, MH, CM, and TK report funding by the Gemeinsamer Bundesausschuss (G-BA; German Innovations Fund of the Federal Joint Committee). During the last three years, MH has received personal fees from Angelini, Bial, Desitin, Eisai, Jazz Pharma, and UCB. IM reports working at Owkin UK Ltd and ASOG for IQVIA Holdings Inc. Their contributions to the submitted work was carried out independently to their respective employment. Outside the content of this paper, TK declares having received research grants from the German Federal Joint Committee (G-BA) and personal compensation from the North-East German Society for Gynecological Oncology (NOGGO), AbbVie, Eli Lilly & Company, Novartis, the BMJ, and Frontiers.
