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
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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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