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

Overview

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

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.

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Data

Datasets cited

• github.com/nazariofelix-ctb/fibromyalgia-li-rtms-pmcf-dataset, at github.com; found in the Zenodo archive record

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

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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.

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