Long-term neuropsychologic outcome of pre-emptive mTOR inhibitor treatment in children with tuberous sclerosis complex (TSC) under 4 months of age (PROTECT), a two-arm, randomized, observer-blind, controlled phase IIb national multicentre clinical trial: study protocol

2025 . Driedger, Jan H. | Schröter, Julian | PROTECT-Study Group | Hertzberg, Christoph | Weschke, Bernhard | Kaindl, Angela M. | Lücke, Thomas | Thiels, Charlotte | Klotz, Kerstin Alexandra | Fazeli, Walid | Rostásy, Kevin | Wiethoff-Ubrig, Lucia | Kaiser, Olaf | Trollmann, Regina | Mammadova, Dilbar | Schubert-Bast, Susanne | Bach, Alexia | Eckenweiler, Matthias | Schönberger, Jan | Martakis, Kyriakos | Hahn, Andreas | Brockmann, Knut | Dreha-Kulaczewski, Steffi | Weiss, Deike | Denecke, Jonas | Muhle, Hiltrud | Arelin, Maria | Merkenschlager, Andreas | Borggräfe, Ingo | Roser, Timo | Ebrahimi-Fakhari, Daniel | Fiedler, Barbara | Schlump, Jan-Ulrich | Köster, Ilka | Korenke, Christoph | Alber, Michael | Ruf, Susanne | Feucht, Martha | Scholl, Theresa | Syrbe, Steffen | Saffari, Afshin