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Current pharmacological and psychotherapeutic treatments are ineffective in a substantial fraction of patients and can be accompanied by unwanted side effects.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Using a novel non-invasive brain stimulation method to specifically target and modulate dysfunctional brain oscillations with high spatial and temporal precision this study will investigate the efficacy of EEG-triggered transcranial magnetic stimulation (TMS) to alleviate depressive symptoms in 28 patients with MDD in a 1:1-randomized, double blind, standard treatment-controlled pilot trial. In the experimental condition, stimulation will be brain oscillation-synchronized based on the EEG-extracted endogenous theta oscillation over left dorsomedial prefrontal cortex (DMPFC). The control condition will consist of standard TMS therapy following an FDA-approved intermittent theta-burst stimulation (iTBS) protocol over left dorsolateral prefrontal cortex (DLPFC). The treatment will be performed over four consecutive weeks (20 sessions) and the primary outcome will be the change in the Montgomery-\u00c5sberg Depression Rating Scale (MADRS) after the last versus before the first treatment session.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The aim of the study is to gain exploratory evidence for the feasibility and efficacy of EEG-synchronized TBS of left DMPFC compared to a standard FDA-approved treatment (iTBS of left DLPFC) in a double-blind randomized parallel-design pilot clinical trial. Positive results will pave the way for a larger RCT to prove the superiority of personalized, brain oscillation-synchronized non-invasive brain stimulation therapies as novel, effective and well-tolerated treatment in MDD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      <jats:italic>Trial Registration<\/jats:italic>\n                      : NCT06345651, date of registration: 2024-01-08,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT06345651\" ext-link-type=\"uri\">https:\/\/clinicaltrials.gov\/study\/NCT06345651<\/jats:ext-link>\n                      The trial is conducted in accord with protocol version number 2022-09, Version 3. Recruitment started in January 2024, and recruitment is ongoing. The recruitment phase is projected to conclude by December 2026.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00406-025-02176-9","type":"journal-article","created":{"date-parts":[[2026,1,21]],"date-time":"2026-01-21T07:03:13Z","timestamp":1768978993000},"page":"1381-1398","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Brain oscillation-synchronized stimulation for major depression: a randomized controlled trial comparing EEG-triggered repetitive TMS with standard iTBS (Acronym: BOSSFRONT2)"],"prefix":"10.1007","volume":"276","clinical-trial-number":[{"clinical-trial-number":"nct06345651","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-0460-172X","authenticated-orcid":false,"given":"Anne","family":"Lieb","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brigitte","family":"Zrenner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Becker-Sadzio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro Caldana","family":"Gordon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G\u00e1bor","family":"Koz\u00e1k","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christoph","family":"Zrenner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Martus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulf","family":"Ziemann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Fallgatter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,1,21]]},"reference":[{"key":"2176_CR1","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1002\/mpr.138","volume":"12","author":"L Andrade","year":"2003","unstructured":"Andrade L, Caraveo-Anduaga JJ, Berglund P, Bijl RV, De Graaf R et al (2003) The epidemiology of major depressive episodes: results from the International Consortium of Psychiatric Epidemiology (ICPE) surveys. 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AJF received grants from the German Ministry of Education and Research (BMBF) and the German Research Foundation (DFG), all not related to the current work. PM received grants from the German Ministry of Education and Research (BMBF) and the German Research Foundation (DFG), all not related to the current work. CZ, BZ and GK declare an interest in the sync2brain GmbH, T\u00fcbingen, Germany, a spin-off start-up company that was formed to commercialize the real-time EEG analysis technology used in this study. The other authors declare that they have no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study was approved on November 7, 2022 by this ethics committee under project number 529\/2019BO1 (see Appendix for approval documents). The study will be conducted in accord with the latest version of the declaration of Helsinki and in accord with the professional code of conduct. Please see the additional files for the original ethical approval and the English translation.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval and consent to participate"}},{"value":"Not applicable. This study protocol manuscript does not contain any identifiable individual data.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Written informed consent will be obtained from all participants or, respectively, their representatives prior to study enrollment.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}