@article{0ebb7b2232ad4e26a0e0ba83a2b51959,
title = "Deep TMS H1 Coil treatment for depression: Results from a large post marketing data analysis",
abstract = "Phase IV study evaluated Deep TMS for major depression in community settings. Data were aggregated from 1753 patients at 21 sites, who received Deep TMS (high frequency or iTBS) using the H1 coil. Outcome measures varied across subjects and included clinician-based scales (HDRS-21) and self-assessment questionnaires (PHQ-9, BDI-II). 1351 patients were included in the analysis, 202 received iTBS. For participants with data from at least 1 scale, 30 sessions of Deep TMS led to 81.6% response and 65.3% remission rate. 20 sessions led to 73.6% response and 58.1% remission rate. iTBS led to 72.4% response and 69.2% remission. Remission rates were highest when assessed with HDRS (72%). In 84% of responders and 80% of remitters, response and remission was sustained in the subsequent assessment. Median number of sessions (days) for onset of sustained response was 16 (21 days) and for sustained remission 17 (23 days). Higher stimulation intensity was associated with superior clinical outcomes. This study shows that beyond its proven efficacy in RCTs, Deep TMS with the H1 coil is effective for treating depression under naturalistic conditions, and the onset of improvement is usually within 20 sessions. However, initial non-responders and non-remitters benefit from extended treatment.",
keywords = "Deep TMS, Depression, Mixture modeling, Phase four, Predictors, Real world evidence, rTMS",
author = "Aron Tendler and Stephan Goerigk and Samuel Zibman and Salom{\'e} Ouaknine and Tal Harmelech and Pell, {Gaby S.} and Abraham Zangen and Harvey, {Steven A.} and Geoffrey Grammer and Jimmy Stehberg and Oluremi Adefolarin and Owen Muir and Carlene MacMillan and Diana Ghelber and Walter Duffy and Irakli Mania and Zeeshan Faruqui and Faisal Munasifi and Todd Antin and Frank Padberg and Yiftach Roth",
note = "Funding Information: Frank Padberg is a member of the European Scientific Advisory Board of Brainsway Inc. Jerusalem, Israel, and the International Scientific Advisory Board of Sooma, Helsinki, Finland. He has received speaker's honoraria from Mag&More GmbH, the neuroCare Group, Munich, Germany, and Brainsway Inc. His lab has received support with equipment from neuroConn GmbH, Ilmenau, Germany, Mag&More GmbH and Brainsway Inc. Aron Tendler, Abraham Zangen, Yiftach Roth, Tal Harmelech, Samuel Zibman, Salom{\'e} Ouaknine and Gaby Pell have a financial interest in BrainsWay. Jimmy Stehberg is a consultant for BrainsWay and for NeuroMagnetics SA. Geoffrey Grammer, Steve Harvey, Oluremi Adefolarin, Faisal Munasifi, and Aron Tendler have an interest in commercial TMS. This work was primarily supported by a Stanley Medical Research Institute (12T-011) grant and was partly developed during FAPESP-BAYLAT bilateral meetings (17/50223-7). Thesponsor had no role in the design and conduct of the study; collection; management; analysis; interpretation of data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. ARB is a Humboldt alumni and receives Humboldt return fellowship and CNPq (1B) productivity grants. The Laboratory of Neuroscience receives financial support from the Beneficent Association Alzira Denise Hertzog da Silva and the CAPES / INCT program “National Institute of Biomarkers in Psychiatry” (INBioN) (FAPESP 14/50873-3). This work was also supported by the German Center for Brain Stimulation (GCBS) research consortium (Work Package 7) [grant number 01EE1403G], funded by the Federal Ministry of Education and Research (BMBF). This work was also funded by FONDECYT #1200452 (JS). The authors wish to thank the support staff and technicians at all the sites for their work supporting this study. Particularly Shlomi Fishman, Amit Ginou and Elyssa Sisko. The authors thank Drs. Richard Naimark, David Schmidt, Saad Shakir, Natalie Lender, Kenneth Melman, Juan Cabrera Jr. David Jones, Jagdeep Kaur, Sabeen Faris, Shahid Insaf, Deborah Kim, Brent Nelson and Sibley Memorial Hospital for contributing data. Funding Information: This work was primarily supported by a Stanley Medical Research Institute (12T-011) grant and was partly developed during FAPESP-BAYLAT bilateral meetings (17/50223-7). Thesponsor had no role in the design and conduct of the study; collection; management; analysis; interpretation of data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. ARB is a Humboldt alumni and receives Humboldt return fellowship and CNPq (1B) productivity grants. The Laboratory of Neuroscience receives financial support from the Beneficent Association Alzira Denise Hertzog da Silva and the CAPES / INCT program “National Institute of Biomarkers in Psychiatry” (INBioN) (FAPESP 14/50873-3). This work was also supported by the German Center for Brain Stimulation (GCBS) research consortium (Work Package 7) [grant number 01EE1403G], funded by the Federal Ministry of Education and Research (BMBF). This work was also funded by FONDECYT #1200452 (JS). The authors wish to thank the support staff and technicians at all the sites for their work supporting this study. Particularly Shlomi Fishman, Amit Ginou and Elyssa Sisko. The authors thank Drs. Richard Naimark, David Schmidt, Saad Shakir, Natalie Lender, Kenneth Melman, Juan Cabrera Jr., David Jones, Jagdeep Kaur, Sabeen Faris, Shahid Insaf, Deborah Kim, Brent Nelson and Sibley Memorial Hospital for contributing data. Publisher Copyright: {\textcopyright} 2023 The Author(s)",
year = "2023",
month = jun,
day = "1",
doi = "10.1016/j.psychres.2023.115179",
language = "English",
volume = "324",
journal = "Psychiatry Research",
issn = "0165-1781",
publisher = "Elsevier Ireland Ltd",
}
