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Real-World Safety and Tolerability of Low-Intensity Repetitive Transcranial Magnetic Stimulation in Fibromyalgia: A Multicenter Observational Cohort Study

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License · 26 lines · 1.4 KB · CC-BY-4.0

  1. MIT License
  3. Copyright (c) 2026 Nazario Felix-Gonzalez, Jose-Maria Gomez-Arguelles, and Ceferino Maestu-Unturbe
  5. Permission is hereby granted, free of charge, to any person obtaining a copy
  6. of this dataset and associated documentation files (the “Materials”), to deal
  7. in the Materials without restriction, including without limitation the rights
  8. to use, copy, modify, merge, publish, distribute, and reproduce copies of
  9. the Materials, subject to the following conditions:
  11. The above copyright notice and this permission notice shall be included in all
  12. copies or substantial portions of the Materials.
  14. The Materials are provided “as is”, without warranty of any kind, express or
  15. implied, including but not limited to the warranties of merchantability,
  16. fitness for a particular purpose, and noninfringement. In no event shall the
  17. authors or copyright holders be liable for any claim, damages, or other
  18. liability, whether in an action of contract, tort, or otherwise, arising from,
  19. out of, or in connection with the Materials or the use or other dealings in
  20. the Materials.
  22. The dataset included in this repository is fully anonymized and is provided
  23. exclusively for scientific transparency, methodological reproducibility, and
  24. exploratory secondary analyses. Users are responsible for complying with all
  25. applicable ethical, legal, and data protection regulations in their respective
  26. jurisdictions.

LICENSE.txt, under CC-BY-4.0 · at the source

Overview

Authors: Nazario Felix-Gonzalez1, Jose-Maria Gomez-Arguelles2, Ceferino Maestu-Unturbe3
ORCID iDs: Nazario Felix-Gonzalez, Ceferino Maestu-Unturbe
  1. Departamento de Arquitectura y Tecnología de Sistemas Informáticos, Escuela Tecnica Superior de Ingenieros Informaticos, Universidad Politecnica de Madrid, 28223 Madrid, Spain
  2. Unidad de Neurología, Hospital Universitario Quironsalud Madrid, 28223 Madrid, Spain
  3. Centro de Tecnologia Biomedica, Universidad Politecnica de Madrid, 28223 Madrid, Spain
Journal: Journal of clinical medicine, volume 15, issue 12, article 4452
Dates: received 9 May 2026; accepted 5 June 2026; published online 9 June 2026; in print June 2026
Type: Research article · Language: English
License: CC BY
Identifiers: DOI · PMCID PMC13301379
Status: code verified (how the code is found and verified)
Categories: other (modality), human (organism), pain (population), clinical / translational (subfield)
Methods: Preprocessing, Connectivity, Statistics
Keywords: fibromyalgia, neuromodulation, low-intensity rTMS, real-world evidence, safety, tolerability
Citations: not cited yet (Europe PMC); 18 references in the paper

Abstract

Background/Objectives: Low-intensity repetitive transcranial magnetic stimulation (Li-rTMS) is an emerging non-invasive neuromodulation approach for fibromyalgia; however, large-scale data on safety and tolerability in routine clinical settings remain limited. This study aimed to evaluate the safety and tolerability of Li-rTMS in patients with fibromyalgia treated in outpatient practice. Methods: A retrospective multicentre observational cohort study was conducted using routinely collected clinical data from nine outpatient centres (November 2020–March 2026). Safety analyses included all patients initiating Li-rTMS treatment (intention-to-treat cohort, n = 1381). The protocol consisted of eight stimulation sessions delivered using a CE-certified medical device. Patient-reported tolerability and perceived symptom changes in three predefined domains (headache, generalized pain, and sleep) were assessed using a standardized 0–10 scale and analysed descriptively, with stratification by age group. Results: Li-rTMS was generally well tolerated across all age groups, including those >65 years. High-intensity symptom worsening was infrequent (headache 3.8%, generalized pain 6.1%, sleep disturbances 2.1%), predominantly mild and self-limited. No serious adverse events were spontaneously reported or clinically identified during routine clinical follow-up, within the limitations inherent to a real-world passive registry framework. Exploratory observations from patient-initiated recall sessions did not suggest an increased adverse symptom burden with repeated exposure. Conclusions: Li-rTMS demonstrated a favourable patient-reported tolerability profile among patients with available follow-up data, characterized by a low frequency of transient high-intensity symptom worsening and the absence of serious adverse events spontaneously reported or clinically identified during routine, non-systematic follow-up. These findings support the feasibility of repeated Li-rTMS administration in outpatient settings; however, due to the observational design and non-systematic follow-up, no conclusions regarding clinical efficacy can be drawn.

Reproduced under the paper's license (CC BY), from the paper cited above.

Repository

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Zenodo 20356452

License: CC-BY-4.0
State: the link answers, verified on 27 September 2026
Evidence: files inventoried
Size: 1 file
Software Heritage: not checked
Found in: the references
Not found: README, license file, CITATION.cff, environment file, tests, continuous integration, documentation
Availability: 1 check, the latest on 27 September 2026: the link answers (HTTP 200)
  • 27 September 2026: the link answers (HTTP 200)
2 files
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Tracing map

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Data

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Data Availability Statement

The data presented in this study are available on request from the corresponding author.

Reproduced under the paper's license (CC BY), from the paper cited above.

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Version 1, 27 September 2026: the first record

Recorded: type, language, journal, volume, issue, pages, dates, 3 authors, 6 keywords, 18 references.

Cite

This paper

Felix-Gonzalez, N., Gomez-Arguelles, J.-M., & Maestu-Unturbe, C. (2026). Real-World Safety and Tolerability of Low-Intensity Repetitive Transcranial Magnetic Stimulation in Fibromyalgia: A Multicenter Observational Cohort Study. Journal of clinical medicine, 15(12), 4452.

BibTeX

@article{felixgonzalez2026real,
author = {Felix-Gonzalez, Nazario and Gomez-Arguelles, Jose-Maria and Maestu-Unturbe, Ceferino},
title = {{Real-World Safety and Tolerability of Low-Intensity Repetitive Transcranial Magnetic Stimulation in Fibromyalgia: A Multicenter Observational Cohort Study}},
journal = {Journal of clinical medicine},
year = {2026},
month = jun,
volume = {15},
number = {12},
pages = {4452},
publisher = {Multidisciplinary Digital Publishing Institute (MDPI)},
issn = {2077-0383},
pmcid = {PMC13301379}
}

RIS

TY - JOUR
AU - Felix-Gonzalez, Nazario
AU - Gomez-Arguelles, Jose-Maria
AU - Maestu-Unturbe, Ceferino
TI - Real-World Safety and Tolerability of Low-Intensity Repetitive Transcranial Magnetic Stimulation in Fibromyalgia: A Multicenter Observational Cohort Study
T2 - Journal of clinical medicine
J2 - J Clin Med
PY - 2026
DA - 2026/06/01
VL - 15
IS - 12
SP - 4452
SN - 2077-0383
PB - Multidisciplinary Digital Publishing Institute (MDPI)
LA - en
ER -

CSL-JSON

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"container-title-short": "J Clin Med",
"volume": "15",
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"page": "4452",
"PMCID": "PMC13301379",
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"publisher": "Multidisciplinary Digital Publishing Institute (MDPI)",
"language": "en",
"issued": {
"date-parts": [
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