Examining tolerability, safety, and blinding in 1032 transcranial electrical stimulation sessions for children and adolescents with neuropsychiatric and neurodevelopmental disorders

Abstract The present study first extensively evaluated the tolerability, safety, and blinding of transcranial direct current stimulation (tDCS) and transcranial random noise stimulation (tRNS) in paediatric clinical populations, composed of 92 children and adolescents (54 females, age range: 8–17 ye...

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Main Authors: Andrea Battisti, Giulia Lazzaro, Luciana Ursumando, Barbara D’Aiello, Valeria Zanna, Floriana Costanzo, Stefano Vicari, Deny Menghini
Format: Article
Language:English
Published: Nature Portfolio 2025-02-01
Series:Scientific Reports
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Online Access:https://doi.org/10.1038/s41598-025-88256-1
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author Andrea Battisti
Giulia Lazzaro
Luciana Ursumando
Barbara D’Aiello
Valeria Zanna
Floriana Costanzo
Stefano Vicari
Deny Menghini
author_facet Andrea Battisti
Giulia Lazzaro
Luciana Ursumando
Barbara D’Aiello
Valeria Zanna
Floriana Costanzo
Stefano Vicari
Deny Menghini
author_sort Andrea Battisti
collection DOAJ
description Abstract The present study first extensively evaluated the tolerability, safety, and blinding of transcranial direct current stimulation (tDCS) and transcranial random noise stimulation (tRNS) in paediatric clinical populations, composed of 92 children and adolescents (54 females, age range: 8–17 years), involving 1032 sessions across neuropsychiatric (i.e., anorexia nervosa) and neurodevelopmental (i.e., attention deficit and hyperactivity disorder, developmental dyscalculia) conditions. It compared adverse events (AEs) occurrence between active and sham transcranial electrical stimulation (tES) conditions (i.e., 528 active vs. 504 sham sessions) as well as tDCS and tRNS (i.e., 772 tDCS sessions vs. 260 tRNS sessions), while considering demographic and emotional-behavioural factors. Results showed tES safety with no “moderate” or “severe” AEs reported; about 77% of sessions were AE-free, supporting tES use in these populations. Itching was the most common symptom, and active sessions were found to be more likely to induce AEs compared to sham sessions. Notably, tRNS had a higher AE likelihood than tDCS, possibly due to experimental differences. In the current study, demographic and emotional-behavioural variables did not significantly affect AEs. Blinding procedures were moderately effective, with about half of participants correctly identifying their condition. As indicated in prior studies, tRNS seems to better preserve blinding integrity. In conclusion, this study provides comprehensive insights into tES tolerability and safety in paediatric clinical populations, emphasizing the need for further AEs exploration in tES and blinding procedure refinement in future research.
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spelling doaj-art-e8c29daba61e44c48bdd5a7fac3f96a62025-02-09T12:33:35ZengNature PortfolioScientific Reports2045-23222025-02-0115111610.1038/s41598-025-88256-1Examining tolerability, safety, and blinding in 1032 transcranial electrical stimulation sessions for children and adolescents with neuropsychiatric and neurodevelopmental disordersAndrea Battisti0Giulia Lazzaro1Luciana Ursumando2Barbara D’Aiello3Valeria Zanna4Floriana Costanzo5Stefano Vicari6Deny Menghini7Child and Adolescent Neuropsychiatry Unit, Bambino Gesù Children’s Hospital, IRCCSChild and Adolescent Neuropsychiatry Unit, Bambino Gesù Children’s Hospital, IRCCSChild and Adolescent Neuropsychiatry Unit, Bambino Gesù Children’s Hospital, IRCCSChild and Adolescent Neuropsychiatry Unit, Bambino Gesù Children’s Hospital, IRCCSChild and Adolescent Neuropsychiatry Unit, Bambino Gesù Children’s Hospital, IRCCSChild and Adolescent Neuropsychiatry Unit, Bambino Gesù Children’s Hospital, IRCCSChild and Adolescent Neuropsychiatry Unit, Bambino Gesù Children’s Hospital, IRCCSChild and Adolescent Neuropsychiatry Unit, Bambino Gesù Children’s Hospital, IRCCSAbstract The present study first extensively evaluated the tolerability, safety, and blinding of transcranial direct current stimulation (tDCS) and transcranial random noise stimulation (tRNS) in paediatric clinical populations, composed of 92 children and adolescents (54 females, age range: 8–17 years), involving 1032 sessions across neuropsychiatric (i.e., anorexia nervosa) and neurodevelopmental (i.e., attention deficit and hyperactivity disorder, developmental dyscalculia) conditions. It compared adverse events (AEs) occurrence between active and sham transcranial electrical stimulation (tES) conditions (i.e., 528 active vs. 504 sham sessions) as well as tDCS and tRNS (i.e., 772 tDCS sessions vs. 260 tRNS sessions), while considering demographic and emotional-behavioural factors. Results showed tES safety with no “moderate” or “severe” AEs reported; about 77% of sessions were AE-free, supporting tES use in these populations. Itching was the most common symptom, and active sessions were found to be more likely to induce AEs compared to sham sessions. Notably, tRNS had a higher AE likelihood than tDCS, possibly due to experimental differences. In the current study, demographic and emotional-behavioural variables did not significantly affect AEs. Blinding procedures were moderately effective, with about half of participants correctly identifying their condition. As indicated in prior studies, tRNS seems to better preserve blinding integrity. In conclusion, this study provides comprehensive insights into tES tolerability and safety in paediatric clinical populations, emphasizing the need for further AEs exploration in tES and blinding procedure refinement in future research.https://doi.org/10.1038/s41598-025-88256-1TESTDCSTRNSPaediatricTreatmentNeuropsychiatry
spellingShingle Andrea Battisti
Giulia Lazzaro
Luciana Ursumando
Barbara D’Aiello
Valeria Zanna
Floriana Costanzo
Stefano Vicari
Deny Menghini
Examining tolerability, safety, and blinding in 1032 transcranial electrical stimulation sessions for children and adolescents with neuropsychiatric and neurodevelopmental disorders
Scientific Reports
TES
TDCS
TRNS
Paediatric
Treatment
Neuropsychiatry
title Examining tolerability, safety, and blinding in 1032 transcranial electrical stimulation sessions for children and adolescents with neuropsychiatric and neurodevelopmental disorders
title_full Examining tolerability, safety, and blinding in 1032 transcranial electrical stimulation sessions for children and adolescents with neuropsychiatric and neurodevelopmental disorders
title_fullStr Examining tolerability, safety, and blinding in 1032 transcranial electrical stimulation sessions for children and adolescents with neuropsychiatric and neurodevelopmental disorders
title_full_unstemmed Examining tolerability, safety, and blinding in 1032 transcranial electrical stimulation sessions for children and adolescents with neuropsychiatric and neurodevelopmental disorders
title_short Examining tolerability, safety, and blinding in 1032 transcranial electrical stimulation sessions for children and adolescents with neuropsychiatric and neurodevelopmental disorders
title_sort examining tolerability safety and blinding in 1032 transcranial electrical stimulation sessions for children and adolescents with neuropsychiatric and neurodevelopmental disorders
topic TES
TDCS
TRNS
Paediatric
Treatment
Neuropsychiatry
url https://doi.org/10.1038/s41598-025-88256-1
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