Boosting Numerical Cognition in Children and Adolescents with Mathematical Learning Disabilities by a Brain-Based Intervention: A Study Protocol for a Randomized, Sham-Controlled Clinical Trial

Giulia Lazzaro, Andrea Battisti, Cristiana Varuzza, Laura Celestini, Pierpaolo Pani, Floriana Costanzo, Stefano Vicari, Roi Cohen Kadosh and Deny Menghini
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Giulia Lazzaro: Child and Adolescent Neuropsychiatry Unit, Department of Neuroscience, Bambino Gesù Children’s Hospital, IRCCS, 00146 Rome, Italy
Andrea Battisti: Child and Adolescent Neuropsychiatry Unit, Department of Neuroscience, Bambino Gesù Children’s Hospital, IRCCS, 00146 Rome, Italy
Cristiana Varuzza: Child and Adolescent Neuropsychiatry Unit, Department of Neuroscience, Bambino Gesù Children’s Hospital, IRCCS, 00146 Rome, Italy
Laura Celestini: Child and Adolescent Neuropsychiatry Unit, Department of Neuroscience, Bambino Gesù Children’s Hospital, IRCCS, 00146 Rome, Italy
Pierpaolo Pani: Department of Physiology and Pharmacology, Sapienza University, 00185 Rome, Italy
Floriana Costanzo: Child and Adolescent Neuropsychiatry Unit, Department of Neuroscience, Bambino Gesù Children’s Hospital, IRCCS, 00146 Rome, Italy
Stefano Vicari: Child and Adolescent Neuropsychiatry Unit, Department of Neuroscience, Bambino Gesù Children’s Hospital, IRCCS, 00146 Rome, Italy
Roi Cohen Kadosh: School of Psychology, Faculty of Health and Medical Sciences, 30AD04 Elizabeth Fry Building, University of Surrey, Guildford GU2 7XH, UK
Deny Menghini: Child and Adolescent Neuropsychiatry Unit, Department of Neuroscience, Bambino Gesù Children’s Hospital, IRCCS, 00146 Rome, Italy

IJERPH, 2021, vol. 18, issue 20, 1-18

Abstract: Numbers are everywhere, and supporting difficulties in numerical cognition (e.g., mathematical learning disability (MLD)) in a timely, effective manner is critical for their daily use. To date, only low-efficacy cognitive-based interventions are available. The extensive data on the neurobiology of MLD have increased interest in brain-directed approaches. The overarching goal of this study protocol is to provide the scientific foundation for devising brain-based and evidence-based treatments in children and adolescents with MLD. In this double-blind, between-subject, sham-controlled, randomized clinical trial, transcranial random noise stimulation (tRNS) plus cognitive training will be delivered to participants. Arithmetic, neuropsychological, psychological, and electrophysiological measures will be collected at baseline (T0), at the end of the interventions (T1), one week (T2) and three months later (T3). We expect that tRNS plus cognitive training will significantly improve arithmetic measures at T1 and at each follow-up (T2, T3) compared with placebo and that such improvements will correlate robustly and positively with changes in the neuropsychological, psychological, and electrophysiological measures. We firmly believe that this clinical trial will produce reliable and positive results to accelerate the validation of brain-based treatments for MLD that have the potential to impact quality of life.

Keywords: specific learning disorders; transcranial electrical stimulation; EEG; evidence-based medicine (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2021
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