Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research
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This article is based on a consensus conference, which took place in Certosa di Pontignano, Siena (Italy) on March 7-9, 2008, intended to update the previous safety guidelines for the application of transcranial magnetic stimulation (TMS) in research and clinical settings. Over the past decade the scientific and medical community has had the opportunity to evaluate the safety record of research studies and clinical applications of TMS and repetitive TMS (rTMS). In these years the number of applications of conventional TMS has grown impressively, new paradigms of stimulation have been developed (e.g., patterned repetitive TMS) and technical advances have led to new device designs and to the real-time integration of TMS with electroencephalography (EEG), positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). Thousands of healthy subjects and patients with various neurological and psychiatric diseases have undergone TMS allowing a better assessment of relative risks. The occurrence of seizures (i.e., the most serious TMS-related acute adverse effect) has been extremely rare, with most of the few new cases receiving rTMS exceeding previous guidelines, often in patients under treatment with drugs which potentially lower the seizure threshold. The present updated guidelines review issues of risk and safety of conventional TMS protocols, address the undesired effects and risks of emerging TMS interventions, the applications of TMS in patients with implanted electrodes in the central nervous system, and safety aspects of TMS in neuroimaging environments. We cover recommended limits of stimulation parameters and other important precautions, monitoring of subjects, expertise of the rTMS team, and ethical issues. While all the recommendations here are expert based, they utilize published data to the extent possible.
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An eight-second delay was enforced between the two TMS pulses to remain within the strictest safety guidelines of TMS stimulation.
“An eight-second delay was enforced between the two pulses to remain within the strictest safety guidelines of TMS stimulation29.”
From BrainNet: A Multi-Person Brain-to-Brain Interface for Direct Collaboration Between Brains (2019) · cites this paper as [29]
Section 4.3 (Seizures; page unavailable) says intervals between stimulation trains are relevant to safety. Section 2.1 (Nomenclature; page unavailable) describes an eight-second pause between periods of intermittent theta-burst stimulation, not between two individual pulses. The paper therefore supports the general safety rationale for spacing stimulation, but not the claim that an eight-second delay between two pulses is required by its strictest guidelines. (LLM, conf=0.82)
Experimental — accuracy not yet measuredThe cTBS intensity was set to 80% of each participant's active motor threshold, a conservative value chosen to minimize stimulation spread from the target region.
“The cTBS intensity was set to 80% of each participant’s active motor threshold, a conservative value chosen to minimize stimulation spread from the target region.”
From Two prefrontal-subcortical circuits estimate controllability and reflect its impact on learning (2026) · cites this paper as [88]
Section 4.3 (page unavailable) says most published TBS studies use 80% of active motor threshold, supporting that intensity as a conventional choice. The paper does not say the citing study used that setting for each participant or that it was chosen to minimize stimulation spread from the target region. Section 7.2 discusses preventing spread of excitation under earlier guidelines for conventional rTMS, not that rationale for cTBS. (LLM, conf=0.83)
Experimental — accuracy not yet measuredTMS treatment is usually well tolerated and presents no serious side effects; the most common side effects reported are transient headaches and local pain.
“Treatment is usually well tolerated and presents no serious side effects. The most common side effects reported are transient headaches and local pain.”
From The Insula: A Brain Stimulation Target for the Treatment of Addiction (2019) · cites this paper as Rossi et al., 2009
More serious side effects of TMS, most notably seizures, are extremely rare and are unlikely when the proper safety guidelines are followed.
“More serious side effects, most notably seizures, are extremely rare and are unlikely when the proper safety guidelines are followed”
From The Insula: A Brain Stimulation Target for the Treatment of Addiction (2019) · cites this paper as Rossi et al., 2009
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- Authors
- Rossi, S., Hallett, M., Rossini, P. M., & Pascual-Leone, A.
- Affiliations
- National Institutes of Health (US)
- Università Campus Bio-Medico (IT)
- Venue
- Clinical Neurophysiology
- Publisher
- Elsevier BV
- Published
- 2009-12
- Volume
- 120
- Issue
- 12
- Pages
- 2008-2039
- ISSN
- 1388-2457 (ISSN-L)
- PMC
- PMC3260536
- OpenAlex
- W2156092714
- Cited by
- 5,367
- References
- 313
- Citations by year
- 2026: 211 · 2025: 305 · 2024: 346 · 2023: 318 · 2022: 358 · 2021: 409 · 2020: 447 · 2019: 439 · 2018: 397 · 2017: 350 · 2016: 345 · 2015: 324 · 2014: 310 · 2013: 277 · 2012: 239
- FWCI
- 111.52
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Clinical Neurophysiology (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Institutional Research Information System (Università degli Studi di Trento) (submittedVersion, other-oa)
- UCL Discovery (University College London) (submittedVersion)
- Institutional Research Information System (Università degli Studi di Brescia) (submittedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Use Siena air (University of Siena) (submittedVersion)
- Funders
- Università degli Studi di Siena
- Biotechnology and Biological Sciences Research Council (BB/F02424X/1)
- National Institute of Neurological Disorders and Stroke
- National Center for Research Resources (K24RR018875)
- Topics
- Life Sciences › Neuroscience › Neurology › Transcranial Magnetic Stimulation Studies
- Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
- Health Sciences › Medicine › Epidemiology › Traumatic Brain Injury Research
- Keywords
- transcranial magnetic stimulation, repetitive transcranial magnetic stimulation, TMS safety, seizure risk, stimulation parameters, implanted electrodes
- MeSH terms
- Hot Temperature, Humans, Italy, Nervous System Diseases, Risk Factors, Practice Guidelines as Topic, Biomedical Research, Transcranial Magnetic Stimulation
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