Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective multicenter randomized controlled trial
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Major depressive disorder (MDD) is a prevalent and disabling condition, and many patients do not respond to available treatments. Deep transcranial magnetic stimulation (dTMS) is a new technology allowing non-surgical stimulation of relatively deep brain areas. This is the first double-blind randomized controlled multicenter study evaluating the efficacy and safety of dTMS in MDD. We recruited 212 MDD outpatients, aged 22-68 years, who had either failed one to four antidepressant trials or not tolerated at least two antidepressant treatments during the current episode. They were randomly assigned to monotherapy with active or sham dTMS. Twenty sessions of dTMS (18 Hz over the prefrontal cortex) were applied during 4 weeks acutely, and then biweekly for 12 weeks. Primary and secondary efficacy endpoints were the change in the Hamilton Depression Rating Scale (HDRS-21) score and response/remission rates at week 5, respectively. dTMS induced a 6.39 point improvement in HDRS-21 scores, while a 3.28 point improvement was observed in the sham group (p=0.008), resulting in a 0.76 effect size. Response and remission rates were higher in the dTMS than in the sham group (response: 38.4 vs. 21.4%, p=0.013; remission: 32.6 vs. 14.6%, p=0.005). These differences between active and sham treatment were stable during the 12-week maintenance phase. dTMS was associated with few and minor side effects apart from one seizure in a patient where a protocol violation occurred. These results suggest that dTMS constitutes a novel intervention in MDD, which is efficacious and safe in patients not responding to antidepressant medications, and whose effect remains stable over 3 months of maintenance treatment.
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In MDD and TRD, TMS targeting predominantly the left dorsolateral prefrontal cortex produces significant antidepressant effects with response and remission rates of 52.2% and 38.2%, respectively.
“MDD and TRD trials targeting predominantly the left dorsolateral prefrontal cortex, show significant antidepressant effects with response and remission rates of 52.2% and 38.2% accordingly [101,104,105,106,107].”
From The Heart’s Electromagnetic Field in Emotions, Empathy and Human Connection: Biosensor-Derived Insights into Heart–Brain Axis Mechanisms and a Basis for Novel BioMagnetoTherapies (2026) · cites this paper as [105]
The dTMS protocol section identifies the left DLPFC as the treatment target, and Efficacy measures reports significant antidepressant effects in patients with MDD who had not benefited from prior treatment. But the reported active-treatment response and remission rates at week 5 are 38.4% and 32.6%, not 52.2% and 38.2%; the latter figures are not supported by this paper. (LLM, conf=0.91)
Experimental — accuracy not yet measuredDeep TMS (dTMS) uses H-coils to extend stimulation to deeper targets and offers more favorable safety and tolerability profiles.
“Deep TMS (dTMS), utilizes H-coils to extend this stimulation to deeper targets, while also offering more favorable safety and tolerability profiles [6,100,101,102,103,104,105].”
From The Heart’s Electromagnetic Field in Emotions, Empathy and Human Connection: Biosensor-Derived Insights into Heart–Brain Axis Mechanisms and a Basis for Novel BioMagnetoTherapies (2026) · cites this paper as [105]
The Discussion describes dTMS H-coils as providing deeper stimulation than standard TMS coils. It also says dTMS was well tolerated by most patients, but does not establish a more favorable safety or tolerability profile than standard TMS; it describes seizure risk as quite similar. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe H-coil was designed to reach deeper cortical pathways and fibers to target subcortical regions without greatly affecting cortical electric fields.
“The H-coil was designed to affect the neuronal pathways and fibers to deeper cortical regions in order to facilitate targeting subcortical regions (without significantly impacting the electric fields in cortical regions) [31].”
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- Authors
- Levkovitz, Y., Isserles, M., Padberg, F., Lisanby, S. H., Bystritsky, A., Xia, G., Tendler, A., Daskalakis, Z. J., Winston, J. L., Dannon, P., Hafez, H. M., Reti, I. M., Morales, O. G., Schlaepfer, T. E., Hollander, E., Berman, J. A., Husain, M. M., Sofer, U., Stein, A., Adler, S., Deutsch, L., Deutsch, F., Roth, Y., George, M. S., & Zangen, A.
- Affiliations
- Tel Aviv University (IL)
- Hadassah Medical Center (IL)
- Ludwig-Maximilians-Universität München (DE)
- Duke University (US)
- University of California, Los Angeles (US)
- University of California, Davis (US)
- Advanced Mental Health Care (US)
- Centre for Addiction and Mental Health (CA)
- Senior Adult Specialty Healthcare; Austin TX USA
- Greater Nashua Mental Health Center; Nashua NH USA
- Johns Hopkins University (US)
- Harvard University (US)
- University Hospital Bonn (DE)
- Spectrum Neuroscience and Treatment Institute (US)
- New York State Psychiatric Institute (US)
- The University of Texas Southwestern Medical Center (US)
- BrainsWay (Israel) (IL)
- A. Stein - Regulatory Affairs Consulting Ltd.; Kfar Saba Israel
- Biostatistical Consulting, BioStats; Israel
- Ben-Gurion University of the Negev (IL)
- Medical University of South Carolina (US)
- ORCID
- Venue
- World Psychiatry
- Publisher
- Wiley
- Published
- 2015-02
- Volume
- 14
- Issue
- 1
- Pages
- 64-73
- ISSN
- 1723-8617 (ISSN-L)
- PMC
- PMC4329899
- OpenAlex
- W2049990060
- Cited by
- 442
- References
- 29
- Citations by year
- 2026: 40 · 2025: 43 · 2024: 46 · 2023: 47 · 2022: 40 · 2021: 37 · 2020: 32 · 2019: 42 · 2018: 28 · 2017: 41 · 2016: 29 · 2015: 17
- FWCI
- 20.44
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- World Psychiatry (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- BrainsWay
- Topics
- Life Sciences › Neuroscience › Neurology › Transcranial Magnetic Stimulation Studies
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
- Keywords
- deep transcranial magnetic stimulation, major depressive disorder, treatment-resistant depression, antidepressant-refractory depression, prefrontal cortex stimulation, treatment response and remission, maintenance therapy, treatment safety
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