PMID- 33165155 OWN - NLM STAT- MEDLINE DCOM- 20210910 LR - 20220420 IS - 1550-509X (Electronic) IS - 0885-9701 (Print) IS - 0885-9701 (Linking) VI - 35 IP - 6 DP - 2020 Nov-Dec TI - Safety Considerations for the Use of Transcranial Magnetic Stimulation as Treatment for Coma Recovery in People With Severe Traumatic Brain Injury. PG - 430-438 LID - 10.1097/HTR.0000000000000636 [doi] AB - OBJECTIVE: For persons in states of disordered consciousness (DoC) after severe traumatic brain injury (sTBI), we report cumulative findings from safety examinations, including serious adverse events (AEs) of a repetitive transcranial magnetic stimulation (rTMS) parameter protocol in 2 different studies. PARTICIPANTS: Seven persons in states of DoC after sTBI with widespread neuropathology, but no large lesions in proximity to the site of rTMS. One participant had a ventriculoperitoneal shunt with programmable valve. METHODS: Two clinical trials each providing 30 rTMS sessions to the right or left dorsolateral prefrontal cortex, involving 300 to 600 pulses over 1 or 2 sessions daily. One study provided concomitant amantadine. Safety indicators monitored related to sleep, temperature, blood pressure, skin integrity, sweating, weight loss, infections, and seizure. RESULTS: Average changes for monitored indicators were of mild severity, with 75 nonserious AEs and 1 serious AE (seizure). The participant incurring a seizure resumed rTMS while taking antieplieptics without further seizure activity. CONCLUSIONS: Considering elevated risks for this patient population and conservative patient selection, findings indicate a relatively safe profile for the specified rTMS protocols; however, potential for seizure induction must be monitored. Future research for this population can be broadened to include patients previously excluded on the basis of profiles raising safety concerns. FAU - Kletzel, Sandra L AU - Kletzel SL AD - The Department of Veterans Affairs (VA), Research Service, Edward Hines Jr VA Hospital, Hines, Illinois (Drs Kletzel, Aaronson, Guernon, Walsh, Patil, Steiner, Pacheco, and Bender Pape and Mr Chaudhry); The Department of Veterans Affairs Mental Health Service Line, Hines VA, Hines, Illinois (Dr Aaronson) Marianjoy Rehabilitation Hospital/Northwestern Medicine, Wheaton, Illinois (Drs Guernon and Bender Pape); Battle Creek VA Medical Center, Kalamazoo, Michigan (Dr Carbone); Department of Physical Medicine and Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, Illinois (Drs Roth, Rosenow, and Bender Pape); Departments of Neurosurgery and Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois (Dr Rosenow); The Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine Chicago, Illinois (Drs Aaronson and Pacheco); Chicago Medical School, Rosalind Franklin University of Science and Medicine, North Chicago, Illinois, (Dr Conneely); Loyola University Chicago, Stritch School of Medicine, Maywood, Illinois (Drs Patil and Steiner); University of Illinois at Chicago, Chicago, Illinois (Mr Chaudhry). FAU - Aaronson, Alexandra L AU - Aaronson AL FAU - Guernon, Ann AU - Guernon A FAU - Carbone, Christina AU - Carbone C FAU - Chaudhry, Noor AU - Chaudhry N FAU - Walsh, Elyse AU - Walsh E FAU - Conneely, Mark AU - Conneely M FAU - Patil, Vijaya AU - Patil V FAU - Roth, Elliott AU - Roth E FAU - Steiner, Monica AU - Steiner M FAU - Pacheco, Marilyn AU - Pacheco M FAU - Rosenow, Joshua AU - Rosenow J FAU - Bender Pape, Theresa L AU - Bender Pape TL LA - eng GR - IK1 RX001850/RX/RRD VA/United States GR - IK1 RX003082/RX/RRD VA/United States GR - IK2 RX002938/RX/RRD VA/United States PT - Clinical Trial PT - Journal Article PL - United States TA - J Head Trauma Rehabil JT - The Journal of head trauma rehabilitation JID - 8702552 SB - IM MH - *Brain Injuries, Traumatic/diagnosis/therapy MH - *Coma/etiology/therapy MH - Humans MH - Prefrontal Cortex MH - Seizures MH - *Transcranial Magnetic Stimulation MH - Treatment Outcome PMC - PMC8908773 MID - NIHMS1663301 COIS- The authors declare no conflicts of interest. EDAT- 2020/11/10 06:00 MHDA- 2021/09/11 06:00 PMCR- 2022/03/10 CRDT- 2020/11/09 14:24 PHST- 2020/11/09 14:24 [entrez] PHST- 2020/11/10 06:00 [pubmed] PHST- 2021/09/11 06:00 [medline] PHST- 2022/03/10 00:00 [pmc-release] AID - 00001199-202011000-00006 [pii] AID - 10.1097/HTR.0000000000000636 [doi] PST - ppublish SO - J Head Trauma Rehabil. 2020 Nov-Dec;35(6):430-438. doi: 10.1097/HTR.0000000000000636.