{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T11:02:14Z","timestamp":1781002934825,"version":"3.54.1"},"reference-count":18,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T00:00:00Z","timestamp":1780963200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>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\u2013March 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\u201310 scale and analysed descriptively, with stratification by age group. Results: Li-rTMS was generally well tolerated across all age groups, including those &gt;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.<\/jats:p>","DOI":"10.3390\/jcm15124452","type":"journal-article","created":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T09:46:54Z","timestamp":1780998414000},"page":"4452","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-World Safety and Tolerability of Low-Intensity Repetitive Transcranial Magnetic Stimulation in Fibromyalgia: A Multicenter Observational Cohort Study"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4433-3707","authenticated-orcid":false,"given":"Nazario","family":"Felix-Gonzalez","sequence":"first","affiliation":[{"name":"Departamento de Arquitectura y Tecnolog\u00eda de Sistemas Inform\u00e1ticos, Escuela Tecnica Superior de Ingenieros Informaticos, Universidad Politecnica de Madrid, 28223 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose-Maria","family":"Gomez-Arguelles","sequence":"additional","affiliation":[{"name":"Unidad de Neurolog\u00eda, Hospital Universitario Quironsalud Madrid, 28223 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2657-9770","authenticated-orcid":false,"given":"Ceferino","family":"Maestu-Unturbe","sequence":"additional","affiliation":[{"name":"Centro de Tecnologia Biomedica, Universidad Politecnica de Madrid, 28223 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,6,9]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1547","DOI":"10.1001\/jama.2014.3266","article-title":"Fibromyalgia: A Clinical Review","volume":"311","author":"Clauw","year":"2014","journal-title":"JAMA"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"600","DOI":"10.1002\/acr.20140","article-title":"The American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia and Measurement of Symptom Severity","volume":"62","author":"Wolfe","year":"2010","journal-title":"Arthritis Care Res."},{"key":"ref_3","first-page":"1141","article-title":"Fibromyalgia: Ongoing Challenges and Recent Advances","volume":"131","author":"Fitzcharles","year":"2018","journal-title":"Am. 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Psychiatry"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/15\/12\/4452\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T10:52:14Z","timestamp":1781002334000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/15\/12\/4452"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,9]]},"references-count":18,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2026,6]]}},"alternative-id":["jcm15124452"],"URL":"https:\/\/doi.org\/10.3390\/jcm15124452","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,9]]}}}