PMID- 25698958 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20150220 LR - 20201001 IS - 1662-5161 (Print) IS - 1662-5161 (Electronic) IS - 1662-5161 (Linking) VI - 9 DP - 2015 TI - Safety and tolerability of theta burst stimulation vs. single and paired pulse transcranial magnetic stimulation: a comparative study of 165 pediatric subjects. PG - 29 LID - 10.3389/fnhum.2015.00029 [doi] LID - 29 AB - BACKGROUND: Although single- and paired-pulse (sp/pp) transcranial magnetic stimulation (TMS) studies are considered minimal risk in adults and children, the safety profile for theta-burst TMS (TBS) is unknown. OBJECTIVE: In this comparative analysis, we explored the rate, severity, and specific symptoms of TMS-related adverse effects (AEs) between sp/ppTMS and TBS in subjects between ages 6 and 18 years. METHOD: Data from 165 participants from 2009 to 2014 were analyzed. Assessment of AEs was performed based on baseline and post-TMS administration of a symptom-based questionnaire that rated AEs on a 5-level ordinal scale (minimal, mild, moderate, marked, severe). AE rates and severity were compared using Chi Square or Fisher's Exact Test depending on data characteristics. RESULT: Overall, no seizures or severe-rated AEs were reported by 165 pediatric participants. The rate of AE in all TBS sessions was 10.5% (n = 76, 95% CI: 4.7-19.7%), whereas the rate of AE in all sp/ppTMS sessions was 12.4% (n = 89, 95% CI: 6.3-21.0%). There was no statistical difference in AE rates between TBS and sp/ppTMS (p = 0.71). In all sp/ppTMS and TBS sessions, 20 subjects reported a total of 35 AEs, among these 31 (~88.6%) were rated as "minimal" or "mild". There was no difference in the severity of AE between TBS and sp/ppTMS (p = 1.0). Only one of 76 TBS participants reported an AE rated as more than minimal/mild. CONCLUSION: Our comparative analysis showed that TBS appears to be as safe as sp/ppTMS in terms of AE rate and severity. This report supports further investigation of TBS in children. FAU - Hong, Yaejee H AU - Hong YH AD - College of Medicine, University of Cincinnati Cincinnati, OH, USA. FAU - Wu, Steve W AU - Wu SW AD - Division of Neurology, Cincinnati Children's Hospital Medical Center Cincinnati, OH, USA. FAU - Pedapati, Ernest V AU - Pedapati EV AD - Division of Neurology, Cincinnati Children's Hospital Medical Center Cincinnati, OH, USA ; Division of Psychiatry, Cincinnati Children's Hospital Medical Center Cincinnati, OH, USA. FAU - Horn, Paul S AU - Horn PS AD - Division of Neurology, Cincinnati Children's Hospital Medical Center Cincinnati, OH, USA. FAU - Huddleston, David A AU - Huddleston DA AD - Division of Neurology, Cincinnati Children's Hospital Medical Center Cincinnati, OH, USA. FAU - Laue, Cameron S AU - Laue CS AD - Division of Psychiatry, Cincinnati Children's Hospital Medical Center Cincinnati, OH, USA. FAU - Gilbert, Donald L AU - Gilbert DL AD - Division of Neurology, Cincinnati Children's Hospital Medical Center Cincinnati, OH, USA. LA - eng GR - R01 MH078160/MH/NIMH NIH HHS/United States GR - R01 MH081854/MH/NIMH NIH HHS/United States PT - Journal Article DEP - 20150204 PL - Switzerland TA - Front Hum Neurosci JT - Frontiers in human neuroscience JID - 101477954 PMC - PMC4316715 OTO - NOTNLM OT - children OT - repetitive transcranial magnetic stimulation OT - safety OT - theta burst stimulation OT - transcranial magnetic stimulation OT - youth EDAT- 2015/02/24 06:00 MHDA- 2015/02/24 06:01 PMCR- 2015/01/01 CRDT- 2015/02/21 06:00 PHST- 2014/12/23 00:00 [received] PHST- 2015/01/12 00:00 [accepted] PHST- 2015/02/21 06:00 [entrez] PHST- 2015/02/24 06:00 [pubmed] PHST- 2015/02/24 06:01 [medline] PHST- 2015/01/01 00:00 [pmc-release] AID - 10.3389/fnhum.2015.00029 [doi] PST - epublish SO - Front Hum Neurosci. 2015 Feb 4;9:29. doi: 10.3389/fnhum.2015.00029. eCollection 2015.