OBJECTIVE: Deep transcranial magnetic stimulation (TMS) with an H-1 coil was recently approved by the U.S. Food and Drug Administration (U.S. FDA) for treatment-resistant depression (TRD) in adults. Studies assessing the safety and effectiveness of deep TMS in adolescent TRD are lacking. The purpose of this brief report is to provide a case history of an adolescent enrolled in an investigational deep TMS protocol. METHODS: A case history is described of the first participant of a sham-controlled clinical trial who had a seizure in the course of deep TMS with parameter settings extrapolated from the adult studies that led to US FDA approval (H-1 coil, 120% target stimulation intensity, 18 Hz, 55 trains of 2-second duration, total 1980 pulses). RESULTS: The participant was a 17-year-old unmedicated female, with no significant medical history and no history of seizures or of drug or alcohol use. Brain magnetic resonance imaging showed no structural abnormalities. She initially received sham, which was well tolerated. During active treatment sessions, titration began at 85% of motor threshold (MT) and increased by 5% per day. Her weekly MT measurements were stable. On her first day of 120% MT (8th active treatment), during the 48th train, the participant had a generalized, tonic-clonic seizure that lasted 90 seconds and resolved spontaneously. She had an emergency medicine evaluation and was discharged home without anticonvulsant medications. There were no further seizures reported at a 6-month follow-up. CONCLUSIONS: We report a deep TMS-induced generalized tonic-clonic seizure in an adolescent with TRD participating in a clinical trial. Given the demonstrated benefits of deep TMS for adult TRD, research investigating its use in adolescents with TRD is an important area. However, in light of this experience, additional precautions for adolescents should be considered. We propose that further dose-finding investigations are needed to refine adolescent-specific parameters that may be safe and effective for treating adolescents with TRD with deep TMS.
OBJECTIVE: Deep transcranial magnetic stimulation (TMS) with an H-1 coil was recently approved by the U.S. Food and Drug Administration (U.S. FDA) for treatment-resistant depression (TRD) in adults. Studies assessing the safety and effectiveness of deep TMS in adolescent TRD are lacking. The purpose of this brief report is to provide a case history of an adolescent enrolled in an investigational deep TMS protocol. METHODS: A case history is described of the first participant of a sham-controlled clinical trial who had a seizure in the course of deep TMS with parameter settings extrapolated from the adult studies that led to US FDA approval (H-1 coil, 120% target stimulation intensity, 18 Hz, 55 trains of 2-second duration, total 1980 pulses). RESULTS: The participant was a 17-year-old unmedicated female, with no significant medical history and no history of seizures or of drug or alcohol use. Brain magnetic resonance imaging showed no structural abnormalities. She initially received sham, which was well tolerated. During active treatment sessions, titration began at 85% of motor threshold (MT) and increased by 5% per day. Her weekly MT measurements were stable. On her first day of 120% MT (8th active treatment), during the 48th train, the participant had a generalized, tonic-clonic seizure that lasted 90 seconds and resolved spontaneously. She had an emergency medicine evaluation and was discharged home without anticonvulsant medications. There were no further seizures reported at a 6-month follow-up. CONCLUSIONS: We report a deep TMS-induced generalized tonic-clonic seizure in an adolescent with TRD participating in a clinical trial. Given the demonstrated benefits of deep TMS for adult TRD, research investigating its use in adolescents with TRD is an important area. However, in light of this experience, additional precautions for adolescents should be considered. We propose that further dose-finding investigations are needed to refine adolescent-specific parameters that may be safe and effective for treating adolescents with TRD with deep TMS.
Authors: Linda L Carpenter; Philip G Janicak; Scott T Aaronson; Terrence Boyadjis; David G Brock; Ian A Cook; David L Dunner; Karl Lanocha; H Brent Solvason; Mark A Demitrack Journal: Depress Anxiety Date: 2012-06-11 Impact factor: 6.505
Authors: Steve W Wu; Nasrin Shahana; David A Huddleston; Amanda N Lewis; Donald L Gilbert Journal: Dev Med Child Neurol Date: 2012-04-19 Impact factor: 5.449
Authors: A Graff-Guerrero; J Gonzáles-Olvera; M Ruiz-García; U Avila-Ordoñez; V Vaugier; J C García-Reyna Journal: Acta Neurol Scand Date: 2004-04 Impact factor: 3.209
Authors: Lindsay M Oberman; Peter G Enticott; Manuel F Casanova; Alexander Rotenberg; Alvaro Pascual-Leone; James T McCracken Journal: Front Hum Neurosci Date: 2015-01-06 Impact factor: 3.169
Authors: Tyler S Kaster; Zafiris J Daskalakis; Yoshihiro Noda; Yuliya Knyahnytska; Jonathan Downar; Tarek K Rajji; Yechiel Levkovitz; Abraham Zangen; Meryl A Butters; Benoit H Mulsant; Daniel M Blumberger Journal: Neuropsychopharmacology Date: 2018-06-18 Impact factor: 7.853
Authors: Simone Rossi; Andrea Antal; Sven Bestmann; Marom Bikson; Carmen Brewer; Jürgen Brockmöller; Linda L Carpenter; Massimo Cincotta; Robert Chen; Jeff D Daskalakis; Vincenzo Di Lazzaro; Michael D Fox; Mark S George; Donald Gilbert; Vasilios K Kimiskidis; Giacomo Koch; Risto J Ilmoniemi; Jean Pascal Lefaucheur; Letizia Leocani; Sarah H Lisanby; Carlo Miniussi; Frank Padberg; Alvaro Pascual-Leone; Walter Paulus; Angel V Peterchev; Angelo Quartarone; Alexander Rotenberg; John Rothwell; Paolo M Rossini; Emiliano Santarnecchi; Mouhsin M Shafi; Hartwig R Siebner; Yoshikatzu Ugawa; Eric M Wassermann; Abraham Zangen; Ulf Ziemann; Mark Hallett Journal: Clin Neurophysiol Date: 2020-10-24 Impact factor: 4.861