Assessment of safety of self-controlled repetitive trans-vertebral magnetic stimulation. Issue 12 (December 2021)

• Record Type: Journal Article
• Authors: Sasada, Syusaku; Kadowaki, Suguru; Tazoe, Toshiki; Murayama, Takashi; Kato, Kenji; Nakao, Yaoki; Matsumoto, Hideyuki; Nishimura, Yukio; Ugawa, Yoshikazu
• Is Part Of: Clinical neurophysiology. Volume 132:Issue 12(2021)
• Page Start: 3166
• Page End: 3176
• Publication Date: 2021-12
• Subjects: Pain -- Repetitive Trans-vertebral Magnetic Stimulation -- Safety issues -- Spinal cord -- Vital signs; AIS American spinal injury association impairment scale -- BP blood pressure -- EMG surface electromyogram -- Eight figure-of-eight coil -- HR heart rate -- ND coil type not defined -- NRS numerical rating score -- Round round coil -- SCDs spinal cord diseases -- SEMS spinal electromagnetic stimulation -- SpO2 peripheral capillary oxygen saturation -- TMS transcranial magnetic stimulation -- TSMS trans-spinal magnetic stimulation -- tsMSS transcutaneous magnetic stimulation of the spine -- TVMS trans-vertebral magnetic stimulation -- rTMS repetitive TMS -- rTVMS repetitive TVMS; Neurophysiology -- Periodicals; Electroencephalography -- Periodicals; Electromyography -- Periodicals; Neurology -- Periodicals; 612.8
• DOI: 10.1016/j.clinph.2021.09.016
• Languages: English
• ISSNs: 1388-2457

Abstract

Highlights: Self-controlled repetitive trans-vertebral magnetic stimulation (rTVMS) induced no serious adverse events. The heart rate was unaffected after self-controlled rTVMS in all participants. "Pain" or "Discomfort" was reported in approximately 10% of trials. Abstract: Objective: The aim of this study was to assess safety issues of self-controlled repetitive trans-vertebral magnetic stimulation (rTVMS) in humans. Methods: We investigated effects of self-controlled rTVMS (≤20 Hz, ≤90% intensity) on vital signs and subjective sensations in 1690 trials of 30 healthy volunteers and 12 patients with spinal cord disorders. Results: Healthy volunteers and the patients received 4595 ± 2345, and 4450 ± 2304 pulses in one day, respectively. No serious adverse events were observed in any participants, and only minor events were seen as follows. While blood pressure was unaffected in the patients, the diastolic blood pressure increased slightly after rTVMS in healthy volunteers. The peripheral capillary oxygen saturation increased after rTVMS in healthy volunteers. "Pain" or "Discomfort" was reported in approximately 10% of trials in both participants groups. Degree of the evoked sensation positively correlated with stimulus intensity and was affected by the site of stimulation. Conclusion: Self-controlled rTVMS (≤20 Hz and ≤90% intensity) did not induce any serious adverse effects in healthy volunteers and patients with spinal cord disorders. Significance: Our results indicate that rTVMS can be used safely in physiological investigations in healthy volunteers and also as treatment for neurological disorders.