Safety, tolerability, and nocebo phenomena during transcranial magnetic stimulation: A systematic review and meta-analysis of placebo-controlled clinical trials
Abstract
Background The methodology used for the application of repetitive transcranial magnetic stimulation (TMS) is such that it may induce a placebo effect. Respectively, adverse events (AEs) can occur when using a placebo, a phenomenon called nocebo. The primary aim of our meta-analysis is to establish the nocebo phenomena during TMS. Safety and tolerability of TMS were also studied. Methods After a systematic Medline search for TMS randomized controlled trials (RCTs), we assessed the number of patients reporting at least one AE and the number of discontinuations because of AE in active and sham TMS groups. Results Data were extracted from 93 RCTs. The overall pooled estimate of active TMS and placebo treated patients who discontinued treatment because of AEs was 2.5% (95% CI 1.9%-3.2%) and 2.7% (95% CI 2.0%-3.5%), respectively. The pooled estimate of active TMS and placebo treated patients experiencing at least one AE was 29.3% (95% CI 19.0%-22.6%) and 13.6% (95% CI 11.6%-15.8%), respectively, suggesting that the odds of experiencing an AE is 2.60 times higher (95% CI 1.75-3.86) in the active treatment group compared to placebo (p < 0.00001). The most common AE was headache, followed by dizziness. Secondary meta-analyses in depression and psychotic disorders showed that the odds of experiencing an AE is 3.98 times higher (95% CI 2.14-7.40) and 2.93 times higher (95% CI 1.41-6.07), respectively, in the active treatment groups compared to placebo. Conclusions TMS is a safe and well-tolerated intervention. Nocebo phenomena do occur during TMS treatment and should be acknowledged during clinical trial design and daily clinical practice.
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Robust evidence has demonstrated the safety and tolerability of rTMS and has suggested that it is superior to sham stimulation on variables of depression severity, response, and remission in adults across the lifespan.
“Robust evidence (e.g., Wallman et al., 2022;Zis et al., 2020) has demonstrated the safety and tolerability of rTMS and has suggested that it is superior to sham stimulation on variables of depression severity, response, and remission in adults across the lifespan (Adu et al., 2022;De Risio et al., 2020;Gaynes et al., 2014).”
From Neurocognitive effects of theta burst stimulation for treatment-resistant depression in adults: A systematic review and recommendations for future research (2025) · cites this paper as Zis et al., 2020
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Rangus, S. R., Tsygankov, B. D., Prosvetov, А. O., & Yurshev, Y. A. (2023) · Vestnik nevrologii psihiatrii i nejrohirurgii (Bulletin of Neurology Psychiatry and Neurosurgery) · doi:10.33920/med-01-2304-01
Unerwünschte Wirkungen, Sicherheit und Überwachung der rTMS
Fitzgerald, P. B., & Daskalakis, Z. J. (2024) · Springer eBooks · doi:10.1007/978-3-031-52844-6_14
Nebenwirkungen der rTMS-Behandlung
Fitzgerald, P. B., & Daskalakis, Z. J. (2024) · Springer eBooks · doi:10.1007/978-3-031-52844-6_15
Evaluating the safety profile of connectome-based repetitive transcranial magnetic stimulation
Tang, S. J., Holle, J., Gabrielsson, E., Dadario, N. B., Ryan, M., Sholas, M. G., Sughrue, M. E., Teo, C., & Yeung, J. T. (2025) · Acta Neuropsychiatrica · doi:10.1017/neu.2025.9
Kerkel, K., Reißmann, A., Langguth, B., Osnabruegge, M., Tomasevic, L., Litschel, K., Kuder, M., Schecklmann, M., & Schoisswohl, S. (2025) · Research Square · doi:10.21203/rs.3.rs-6915977/v1
Zhang, S., Liu, S., Gu, C., Zhang, R., Zhang, Y., Wang, M., & Xu, X. (2025) · Frontiers in Neurology · doi:10.3389/fneur.2025.1581467
Souki, A., Sharifzadeh, S., Brady, K. T., Hanlon, C. A., Jha, M. K., Lim, K. O., Rakesh, G., Young, J. R., Steele, V. R., Tang, V. M., et al. (2026) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2026.113297
Kerkel, K., Reißmann, A., Langguth, B., Osnabruegge, M., Tomasevic, L., Litschel, K., Kuder, M., Schecklmann, M., & Schoisswohl, S. (2025) · Research Square · doi:10.21203/rs.3.rs-6915977/v2
The potential application of electrophysiological indicators in TMS treatment for MOH
Xiao, D., Han, H., Guo, H., Li, Z., He, Y., Ma, J., & Jiang, H. (2025) · Frontiers in Pain Research · doi:10.3389/fpain.2025.1689847
Koelsch, C., Mirlach, T., Kinfe, T. M., Hurlemann, R., Mutz, J., Selaskowski, B., & Kiebs, M. (2026) · BMJ Open · doi:10.1136/bmjopen-2025-107577
A Brief Mindfulness Intervention for Pain Management in Fibromyalgia: A Single-arm Open-Label Study
Ramasawmy, P., Heim, L. C., Fechner, E., Schumann, S. E., Mai, T. T., Moschner, O., Jiang, Y., Guo, X., Lesani, A., Petzke, F. W., et al. (2026) · Restorative Neurology and Neuroscience · doi:10.1177/09226028251410014
Kerkel, K., Reißmann, A., Langguth, B., Osnabruegge, M., Tomasevic, L., Litschel, K., Kuder, M., Schecklmann, M., & Schoisswohl, S. (2026) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2026.1731673
Xu, R., Wen, G., Wang, Y., Wang, X., Luo, Y., Yang, L., Gai, X., & Li, L. (2026) · Frontiers in Rehabilitation Sciences · doi:10.3389/fresc.2026.1668986
Uehara, M. A., Bretecher, C. A., Teschuk, J. M., Verot, A., Saha, C., Fitzgerald, P. B., Koski, L. M., Millikin, C., & Moussavi, Z. (2026) · Psychiatry Research · doi:10.1016/j.psychres.2026.117212
Prescribed Interventions to Reduce Depression
Sunzeri, F. (2026) · Springer eBooks · doi:10.1007/978-3-032-14465-2_22
Why health authorities should endorse rTMS for treatment-resistant depression
Batail, J.-M. V., Raphaël Gaillard, B., Haffen, É., Poulet, E., Sauvaget, A., Szekely, D., Brunelin, J., Bulteau, S., Bubrovszky, M., Smadja, J., et al. (2026) · Transcranial magnetic stimulation . · doi:10.1016/j.transm.2026.100321
Is there a place for non-invasive brain stimulation in the treatment of schizophrenia?
Fitzgerald, P. B. (2026) · Australian & New Zealand Journal of Psychiatry · doi:10.1177/00048674261470630
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- Authors
- Zis, P., Shafique, F., Hadjivassiliou, M., Blackburn, D., Venneri, A., Iliodromiti, S., Mitsikostas, D.-D., & Sarrigiannis, P. G.
- Affiliations
- University of Cyprus (CY)
- Sheffield Teaching Hospitals NHS Foundation Trust (GB)
- University of Sheffield (GB)
- University of Glasgow (GB)
- National and Kapodistrian University of Athens (GR)
- Corresponding author
- Zis, Panagiotis
- ORCID
- Venue
- Neuromodulation: Technology at the Neural Interface
- Publisher
- Elsevier BV
- Published
- 2020-04
- Volume
- 23
- Issue
- 3
- Pages
- 291-300
- ISSN
- 1094-7159 (ISSN-L)
- OpenAlex
- W2923341069
- Cited by
- 77
- References
- 33
- Citations by year
- 2026: 11 · 2025: 9 · 2024: 10 · 2023: 10 · 2022: 12 · 2021: 10 · 2020: 12 · 2019: 3
- FWCI
- 0.96
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Neuromodulation Technology at the Neural Interface (publishedVersion)
- PubMed (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- Topics
- Life Sciences › Neuroscience › Neurology › Transcranial Magnetic Stimulation Studies
- Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
- Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
- Keywords
- repetitive transcranial magnetic stimulation, nocebo effect, placebo effect, adverse events, treatment safety, tolerability, sham stimulation, headache, dizziness, depression, psychosis
- MeSH terms
- Female, Humans, Male, Transcranial Magnetic Stimulation, Nocebo Effect
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