What large multi‑site randomized trials of rTMS for tinnitus are planned or funded since 2023?
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Executive summary
A review of the supplied reporting finds no clear, new large multi‑site randomized trials of rTMS for tinnitus that were explicitly planned or funded since 2023; the literature instead emphasizes a continuing need for such trials and documents several earlier multicenter efforts and pilot multisite protocols that shaped current thinking [1] [2] [3]. The most prominent multi‑site randomized work referenced in these sources predates 2023 (notably a 2017 German multicenter trial funded by the Deutsche Forschungsgemeinschaft) and ongoing EU efforts such as the UNITI project are multi‑center but address a spectrum of tinnitus interventions rather than a single, newly funded large rTMS RCT launched since 2023 [3] [4].
1. The state of play: calls for large multicenter rTMS trials remain loud and recent
Multiple systematic reviews and recent overviews report heterogenous rTMS results and explicitly call for randomized, sham‑controlled, adequately powered multicenter trials to resolve efficacy questions—this recommendation is reiterated in reviews through 2023 and in papers summarizing two large but divergent trials from earlier years [2] [1] [5]. These sources document the consensus among investigators that small, heterogeneous single‑center studies and inconsistent stimulation parameters have left open whether rTMS can reliably help chronic tinnitus patients [2] [1].
2. What large multicenter randomized trials exist in the record supplied (pre‑2023)?
The largest multicenter randomized rTMS trial cited in the reporting is the 1‑Hz rTMS sham‑controlled multicenter study published from Germany, which reported a negative result for the tested protocol and was funded by the German Research Foundation (Deutsche Forschungsgemeinschaft) [3]. Earlier multisite or pilot multisite protocols—such as triple‑site and dual‑site stimulation trials and the multisite protocol tested in pilot work—also appear in the literature and shaped later trial designs [6] [7] [8].
3. Multi‑center programs that include rTMS but are broader than a single rTMS RCT
The UNITI EU project is a documented multi‑center randomized clinical trial platform spanning five sites that aims to compare and unify different tinnitus treatments, including neurostimulation among many interventions, and to support personalized decision tools—UNITI is multi‑center and randomized but is not limited to a single large rTMS RCT; its protocol and scope are described in the project literature [4]. This kind of program can host rTMS arms but, in the provided reporting, was not presented as a newly funded large, dedicated multi‑site rTMS trial initiated since 2023 [4].
4. Evidence of trials published around or after 2023 and what that implies
Meta‑analyses and RCT aggregations that include trials up through 2023 note inclusion of newer trials (for example Li et al., 2023 is listed among RCTs in later meta‑analytic work), but these syntheses do not identify a discrete, new large multicenter rTMS trial launched or funded after 2023 in the supplied materials; rather, they treat 2021–2023 RCTs as adding to the heterogeneous body of modestly sized studies that still leave long‑term efficacy unresolved [9] [10].
5. Why no obvious "since‑2023" megatrial appears in this reporting—and the practical obstacles
The reporting indicates persistent scientific calls for large multicenter trials and documents past examples of public research funding (e.g., DFG funding of the 1‑Hz multicenter trial), but it does not show a named, newly funded, large multisite rTMS RCT announced or registered since 2023; this gap likely reflects the slow, resource‑intensive nature of multicenter neuromodulation trials, the heterogeneity of tinnitus, and competing funding priorities—assertions supported by repeated calls for multicenter work in reviews up to 2023 [3] [1] [2].
6. Alternative perspectives, agendas, and what readers should watch for
Investigators advocating for personalized or multisite stimulation protocols argue these approaches may outperform single‑site low‑frequency protocols—a view reflected in pilot and dual/triple‑site RCTs cited in the literature—whereas systematic negative findings from large past multicenter work (e.g., the 1‑Hz DFG‑funded study) temper enthusiasm and shape funders’ caution [7] [6] [3]. Industry advances in other neuromodulation devices (for example, auditory neuromodulation devices receiving regulatory attention) show commercial pathways differ from academic rTMS trials and may redirect investment away from large rTMS RCTs [11]. The provided reporting does not permit definitive statements about unreported or privately funded trials initiated after 2023; it only allows the conclusion that no clearly documented, newly funded, large multi‑site randomized rTMS trial since 2023 appears in these sources [1] [4] [2].