Cullen Kathryn R, Jasberg Suzanne, Nelson Brent, Klimes-Dougan Bonnie, Lim Kelvin O, Croarkin Paul E
1 Department of Psychiatry, University of Minnesota , Minneapolis, Minnesota.
2 Department of Psychiatry and Psychology, Mayo Clinic , Rochester, Minnesota.
J Child Adolesc Psychopharmacol. 2016 Sep;26(7):637-41. doi: 10.1089/cap.2016.0070. Epub 2016 Jul 22.
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.
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).
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.
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.
采用H - 1线圈的深部经颅磁刺激（TMS）最近获得了美国食品药品监督管理局（U.S. FDA）批准，用于治疗成人难治性抑郁症（TRD）。目前缺乏评估深部TMS治疗青少年TRD安全性和有效性的研究。本简要报告的目的是提供一名参与深部TMS研究方案的青少年的病例史。
描述了一项假对照临床试验的首例参与者的病例史，该参与者在深部TMS过程中发生癫痫发作，其参数设置是根据导致美国FDA批准的成人研究（H - 1线圈，120%目标刺激强度，18 Hz，55串，每串持续2秒，共1980个脉冲）外推而来。
该参与者为一名17岁未服药的女性，无重大病史，无癫痫发作史，也无药物或酒精使用史。脑磁共振成像显示无结构异常。她最初接受假刺激，耐受性良好。在积极治疗阶段，滴定从运动阈值（MT）的85%开始，每天增加5%。她每周的MT测量值稳定。在达到120% MT的第一天（第8次积极治疗），在第48串刺激期间，该参与者发生了一次全身性强直阵挛性癫痫发作，持续90秒，随后自行缓解。她接受了急诊评估，未使用抗惊厥药物便出院回家。在6个月的随访中未报告进一步的癫痫发作。
我们报告了一名患有TRD的青少年在参与一项临床试验时发生深部TMS诱发的全身性强直阵挛性癫痫发作。鉴于深部TMS对成人TRD已证实的益处，研究其在青少年TRD中的应用是一个重要领域。然而，鉴于这一经验，应考虑针对青少年的额外预防措施。我们建议需要进一步进行剂量探索研究，以完善可能对深部TMS治疗青少年TRD安全有效的青少年特定参数。
