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.
Bibliographical noteFunding Information:
Importantly, we are grateful to the caregivers and children in our studies who made this work, and understanding, possible. We kindly acknowledge the editing and proofing of Sally Jones. Funding sources are 1UL1RR033183-01NCRR (BG), 8UL1TR000114-02 (BG), UL1TR000114 NCATS (BG), NIH NICHD 1K01HD078484-01A1 (BG), MN Med Fnd (BG), FPT (BG), CPF (BG), NS062116 (KF), Columbia Professional Schools Diversity Award (KF), NIH CTSA Award (KL2 RR024157, UL1 RR024156, TL1 RR024158) (KF), HD076436 (KF), NIH NINDS K08 NS073796 (JC), AACPDM Student Travel award (TR), and UMN MnDRIVE Fellowship (TR)
- Cerebral palsy
- Non-invasive brain stimulation
- Repetitive transcranial magnetic stimulation
- Transcranial direct current stimulation
- Transcranial magnetic stimulation