Should transcranial magnetic stimulation research in children be considered minimal risk?
OBJECTIVE
Transcranial magnetic stimulation (TMS) is a neurophysiologic technique with research applications. Institutional Review Boards (IRBs) must carefully consider potential risks and possible benefits in research involving children. The purpose of this study is to provide concise information for investigators and IRBs about the safety of single and paired pulse TMS research in children.


METHODS
This paper has 4 sections: (I) Regulations governing research in children are reviewed and applied to the use of TMS. (II) Energy imparted by TMS is assessed in terms of theoretical biological risks to human subjects. (III) Through MEDLINE review, the empirical evidence of risk from TMS is assessed. Reported adverse events, including issues related to risk of seizures and of hearing loss, are summarized. (IV) Safety data are presented from a study of TMS in children with Tourette Syndrome.


RESULTS
No published or empirical evidence was found to suggest that single or paired pulse TMS is associated with more than minimal risk in children.


CONCLUSIONS
IRBs may consider well-designed studies using single and paired pulse TMS protocols similar to those described in this study as bearing minimal risk to children.


CONCLUSIONS
This manuscript may be useful as a reference to IRBs and TMS investigators.
Gilbert
Donald L
DL
Division of Pediatric Neurology, Movement Disorders Clinics, Cincinnati Children's Hospital Medical Center, ML# 2015, 3333 Burnet Avenue, Cincinnati, OH 45229-3039, USA. d.gilbert@cchmc.org
Garvey
Marjorie A
MA
Bansal
Alok S
AS
Lipps
Tara
T
Zhang
Jie
J
Wassermann
Eric M
EM
D000328:Adult; D001921:Brain / Q000502:physiology; D002648:Child; D055590:Electromagnetic Phenomena / Q000379:methods / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D005879:Tourette Syndrome / Q000503:physiopathology / Q000628:therapy*