Non-invasive brain stimulation in children with unilateral cerebral palsy: A protocol and risk mitigation guide

Bernadette T. Gillick; Andrew M. Gordon; Tim Feyma; Linda E. Krach; Jason Carmel; Tonya L. Rich; Yannick Bleyenheuft; Kathleen Friel

doi:10.3389/fped.2018.00056

Non-invasive brain stimulation in children with unilateral cerebral palsy: A protocol and risk mitigation guide

Bernadette T. Gillick, Andrew M. Gordon, Tim Feyma, Linda E. Krach, Jason Carmel, Tonya L. Rich, Yannick Bleyenheuft, Kathleen Friel

Physical Therapy

Research output: Contribution to journal › Article › peer-review

21 Scopus citations

Abstract

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.

Original language	English (US)
Article number	56
Journal	Frontiers in Pediatrics
Volume	6
DOIs	https://doi.org/10.3389/fped.2018.00056
State	Published - Mar 16 2018

Bibliographical note

Funding 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)

Publisher Copyright:
© 2018 Gillick, Gordon, Feyma, Krach, Carmel, Rich, Bleyenheuft and Friel.

Keywords

Cerebral palsy
Children
Non-invasive brain stimulation
Repetitive transcranial magnetic stimulation
Risk
Safety
Transcranial direct current stimulation
Transcranial magnetic stimulation

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access

10.3389/fped.2018.00056

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5864860

OpenUrl availability

Full text

Cite this

@article{890e9bb46c084f0bbdf5ac8334b2a7f9,

title = "Non-invasive brain stimulation in children with unilateral cerebral palsy: A protocol and risk mitigation guide",

abstract = "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.",

keywords = "Cerebral palsy, Children, Non-invasive brain stimulation, Repetitive transcranial magnetic stimulation, Risk, Safety, Transcranial direct current stimulation, Transcranial magnetic stimulation",

author = "Gillick, {Bernadette T.} and Gordon, {Andrew M.} and Tim Feyma and Krach, {Linda E.} and Jason Carmel and Rich, {Tonya L.} and Yannick Bleyenheuft and Kathleen Friel",

note = "Funding 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) Publisher Copyright: {\textcopyright} 2018 Gillick, Gordon, Feyma, Krach, Carmel, Rich, Bleyenheuft and Friel.",

year = "2018",

month = mar,

day = "16",

doi = "10.3389/fped.2018.00056",

language = "English (US)",

volume = "6",

journal = "Frontiers in Pediatrics",

issn = "2296-2360",

publisher = "Frontiers Media S. A.",

}

TY - JOUR

T1 - Non-invasive brain stimulation in children with unilateral cerebral palsy

T2 - A protocol and risk mitigation guide

AU - Gillick, Bernadette T.

AU - Gordon, Andrew M.

AU - Feyma, Tim

AU - Krach, Linda E.

AU - Carmel, Jason

AU - Rich, Tonya L.

AU - Bleyenheuft, Yannick

AU - Friel, Kathleen

N1 - Funding 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) Publisher Copyright: © 2018 Gillick, Gordon, Feyma, Krach, Carmel, Rich, Bleyenheuft and Friel.

PY - 2018/3/16

Y1 - 2018/3/16

N2 - 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.

AB - 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.

KW - Cerebral palsy

KW - Children

KW - Non-invasive brain stimulation

KW - Repetitive transcranial magnetic stimulation

KW - Risk

KW - Safety

KW - Transcranial direct current stimulation

KW - Transcranial magnetic stimulation

UR - http://www.scopus.com/inward/record.url?scp=85045300367&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85045300367&partnerID=8YFLogxK

U2 - 10.3389/fped.2018.00056

DO - 10.3389/fped.2018.00056

M3 - Article

C2 - 29616203

AN - SCOPUS:85045300367

SN - 2296-2360

VL - 6

JO - Frontiers in Pediatrics

JF - Frontiers in Pediatrics

M1 - 56

ER -

Non-invasive brain stimulation in children with unilateral cerebral palsy: A protocol and risk mitigation guide

Abstract

Bibliographical note

Keywords

UN SDGs

Access

OpenUrl availability

Other files and links

Fingerprint

Cite this