Gillick Bernadette T, Gordon Andrew M, Feyma Tim, Krach Linda E, Carmel Jason, Rich Tonya L, Bleyenheuft Yannick, Friel Kathleen
Physical Therapy Division, Department of Rehabilitation Medicine, University of Minnesota, Minneapolis, MN, United States.
Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY, United States.
Front Pediatr. 2018 Mar 16;6:56. doi: 10.3389/fped.2018.00056. eCollection 2018.
Non-invasive brain stimulation has been increasingly investigated, mainly in adults, with the aims of influencing motor recovery after stroke. However, a consensus on safety and optimal study design has not been established in pediatrics. The low incidence of reported major adverse events in adults with and without clinical conditions has expedited the exploration of NIBS in children with paralleled purposes to influence motor skill development after neurological injury. Considering developmental variability in children, with or without a neurologic diagnosis, adult dosing and protocols may not be appropriate. The purpose of this paper is to present recommendations and tools for the prevention and mitigation of adverse events (AEs) during NIBS in children with unilateral cerebral palsy (UCP). Our recommendations provide a framework for pediatric NIBS study design. The key components of this report on NIBS AEs are (a) a summary of related literature to provide the background evidence and (b) tools for anticipating and managing AEs from four international pediatric laboratories. These recommendations provide a preliminary guide for the assessment of safety and risk mitigation of NIBS in children with UCP. Consistent reporting of safety, feasibility, and tolerability will refine NIBS practice guidelines contributing to future clinical translations of NIBS.
非侵入性脑刺激越来越受到研究，主要针对成年人，目的是影响中风后的运动恢复。然而，在儿科领域，关于安全性和最佳研究设计尚未达成共识。在有或没有临床疾病的成年人中，报告的重大不良事件发生率较低，这加速了对儿童进行非侵入性脑刺激的探索，其目的与影响神经损伤后运动技能发展相似。考虑到儿童的发育变异性，无论有无神经学诊断，成人的剂量和方案可能并不合适。本文的目的是提出预防和减轻单侧脑瘫（UCP）儿童在非侵入性脑刺激期间不良事件（AE）的建议和工具。我们的建议为儿科非侵入性脑刺激研究设计提供了一个框架。本关于非侵入性脑刺激不良事件报告的关键组成部分包括：（a）相关文献综述，以提供背景证据；（b）来自四个国际儿科实验室的不良事件预测和管理工具。这些建议为评估UCP儿童非侵入性脑刺激的安全性和风险减轻提供了初步指导。对安全性、可行性和耐受性的一致报告将完善非侵入性脑刺激实践指南，为非侵入性脑刺激未来的临床转化做出贡献。
