Anna Ferrulli1,2, Stefano Massarini2, Concetta Macrì2, Livio Luzi3,4. 1. Department of Biomedical Sciences for Health, University of Milan, Via Mangiagalli 31, 20133, Milan, Italy. 2. Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Via Milanese 300, 20099, Sesto San Giovanni (MI), Italy. 3. Department of Biomedical Sciences for Health, University of Milan, Via Mangiagalli 31, 20133, Milan, Italy. livio.luzi@multimedica.it. 4. Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Via Milanese 300, 20099, Sesto San Giovanni (MI), Italy. livio.luzi@multimedica.it.
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.
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 obesepatients 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.
Entities:
Keywords:
Adverse events; Obesity; Safety; Transcranial magnetic stimulation
Authors: Mark S George; Frank Padberg; Thomas E Schlaepfer; John P O'Reardon; Paul B Fitzgerald; Ziad H Nahas; Marco A Marcolin Journal: Brain Stimul Date: 2008-06-27 Impact factor: 8.955