Deep TMS H1 Coil treatment for depression: Results from a large post marketing data analysis

Aron Tendler; Stephan Goerigk; Samuel Zibman; Salomé Ouaknine; Tal Harmelech; Gaby S. Pell; Abraham Zangen; Steven A. Harvey; Geoffrey Grammer; Jimmy Stehberg; Oluremi Adefolarin; Owen Muir; Carlene MacMillan; Diana Ghelber; Walter Duffy; Irakli Mania; Zeeshan Faruqui; Faisal Munasifi; Todd Antin; Frank Padberg; Yiftach Roth

doi:10.1016/j.psychres.2023.115179

Deep TMS H1 Coil treatment for depression: Results from a large post marketing data analysis

Aron Tendler, Stephan Goerigk, Samuel Zibman, Salomé Ouaknine, Tal Harmelech, Gaby S. Pell, Abraham Zangen, Steven A. Harvey, Geoffrey Grammer, Jimmy Stehberg, Oluremi Adefolarin, Owen Muir, Carlene MacMillan, Diana Ghelber, Walter Duffy, Irakli Mania, Zeeshan Faruqui, Faisal Munasifi, Todd Antin, Frank PadbergYiftach Roth

Research output: Contribution to journal › Article › peer-review

9 Citations (Scopus)

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.

Original language	English
Article number	115179
Journal	Psychiatry Research
Volume	324
DOIs	https://doi.org/10.1016/j.psychres.2023.115179
Publication status	Published - Jun 2023

Keywords

Deep TMS
Depression
Mixture modeling
Phase four
Predictors
Real world evidence
rTMS

ASJC Scopus subject areas

Psychiatry and Mental health
Biological Psychiatry

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.psychres.2023.115179

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Tendler, A., Goerigk, S., Zibman, S., Ouaknine, S., Harmelech, T., Pell, G. S., Zangen, A., Harvey, S. A., Grammer, G., Stehberg, J., Adefolarin, O., Muir, O., MacMillan, C., Ghelber, D., Duffy, W., Mania, I., Faruqui, Z., Munasifi, F., Antin, T., ... Roth, Y. (2023). Deep TMS H1 Coil treatment for depression: Results from a large post marketing data analysis. Psychiatry Research, 324, Article 115179. https://doi.org/10.1016/j.psychres.2023.115179

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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 = "Publisher Copyright: {\textcopyright} 2023 The Author(s)",

year = "2023",

month = jun,

doi = "10.1016/j.psychres.2023.115179",

language = "English",

volume = "324",

journal = "Psychiatry Research",

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Tendler, A, Goerigk, S, Zibman, S, Ouaknine, S, Harmelech, T, Pell, GS, Zangen, A, Harvey, SA, Grammer, G, Stehberg, J, Adefolarin, O, Muir, O, MacMillan, C, Ghelber, D, Duffy, W, Mania, I, Faruqui, Z, Munasifi, F, Antin, T, Padberg, F & Roth, Y 2023, 'Deep TMS H1 Coil treatment for depression: Results from a large post marketing data analysis', Psychiatry Research, vol. 324, 115179. https://doi.org/10.1016/j.psychres.2023.115179

TY - JOUR

T1 - Deep TMS H1 Coil treatment for depression

T2 - Results from a large post marketing data analysis

AU - Tendler, Aron

AU - Goerigk, Stephan

AU - Zibman, Samuel

AU - Ouaknine, Salomé

AU - Harmelech, Tal

AU - Pell, Gaby S.

AU - Zangen, Abraham

AU - Harvey, Steven A.

AU - Grammer, Geoffrey

AU - Stehberg, Jimmy

AU - Adefolarin, Oluremi

AU - Muir, Owen

AU - MacMillan, Carlene

AU - Ghelber, Diana

AU - Duffy, Walter

AU - Mania, Irakli

AU - Faruqui, Zeeshan

AU - Munasifi, Faisal

AU - Antin, Todd

AU - Padberg, Frank

AU - Roth, Yiftach

PY - 2023/6

Y1 - 2023/6

N2 - 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.

AB - 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.

KW - Deep TMS

KW - Depression

KW - Mixture modeling

KW - Phase four

KW - Predictors

KW - Real world evidence

KW - rTMS

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U2 - 10.1016/j.psychres.2023.115179

DO - 10.1016/j.psychres.2023.115179

M3 - Article

C2 - 37030054

AN - SCOPUS:85151615726

SN - 0165-1781

VL - 324

JO - Psychiatry Research

JF - Psychiatry Research

M1 - 115179

ER -

Deep TMS H1 Coil treatment for depression: Results from a large post marketing data analysis

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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