Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity
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ORIGINAL ARTICLE
Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity Anna Ferrulli1,2 Stefano Massarini2 Concetta Macrì2 Livio Luzi ●
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Received: 9 June 2020 / Accepted: 7 September 2020 © The Author(s) 2020
Abstract Purpose Repetitive Transcranial Magnetic Stimulation (rTMS) has been demonstrated to be effective in body weight control in individuals with obesity. Most clinical trials on rTMS provided a reassuring safety profile. In the present work, we present an extensive analysis on both severe and mild Adverse Events (AEs) in obese individuals treated with rTMS. Methods We examined the intensity, duration, correlation with the treatment, up to 1 year after the end of rTMS treatment. Results Descriptive analysis included a total of 63 subjects undergoing a 5-week deep rTMS experimental treatment for obesity (age 48.3 ± 10.4 years; BMI 36.3 ± 4.4 kg/m2): 31 patients were treated with high-frequency rTMS (HF), 13 with low-frequency rTMS (LF), and 19 were sham treated (Sham). Thirty-two subjects (50.8%) reported a total of 52 AEs, including mainly moderate (51.9%) events. The most frequently reported side effects were headaches of moderate intensity (40.4%) and local pain/discomfort (19.2%) and resulted significantly more frequent in HF group compared to other groups (p < 0.05). No significant differences among groups were found for the other reported AEs: drowsiness, insomnia, paresthesia, vasovagal reactions, hypertensive crisis. No AEs potentially related to the rTMS arised up to 1 year from the end of the treatment. Conclusions This is the first comprehensive safety analysis in obese patients treated with rTMS. The analysis did not reveal any unexpected safety concerns. Only headaches and local pain/discomfort have been significantly more frequent in the HF group, confirming the good tolerability of rTMS even in the obese population potentially more susceptible to side effects of brain stimulation. Keywords Transcranial magnetic stimulation Safety Adverse events Obesity ●
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Highlights A safety analysis in obese individuals treated with TMS did not reveal any unexpected safety concern up to 1 year after the end of the treatment. ● Only headache and local pain/discomfort have been significantly more frequent in the high-frequency TMS-treated group compared with low-frequency and sham-treated groups. ● TMS exhibits a good safety profile in the obese population potentially more susceptible to side effects of brain stimulation. ●
* Livio Luzi [email protected] 1
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Department of Biomedical Sciences for Health, University of Milan, Via Mangiagalli 31, 20133 Milan, Italy Present address: Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Via Milanese 300, 20099 Sesto San Giovanni (MI), Italy
Abbreviations rTMS repetitive transcranial magnetic stimulation AEs adverse events BMI body mass index HF high frequency LF low frequency RMT resting motor threshold FDA Food and Drug Administration SA
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