Assessment of safety of self-controlled repetitive trans-vertebral magnetic stimulation

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. (c) 2021 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Automated summary

The study aimed to assess safety issues of self-controlled repetitive trans-vertebral magnetic stimulation (rTVMS) in humans and found no serious adverse events in any participants. The results indicate that rTVMS can be used safely in physiological investigations in healthy volunteers and as treatment for neurological disorders.