Child and Adolescent Neuropsychiatry Unit, Department of Neuroscience, Bambino Gesù Children's Hospital, IRCCS, 00146 Rome, Italy.
Department of Human Science, LUMSA University, 00193 Rome, Italy.
Int J Environ Res Public Health. 2021 Oct 19;18(20):10969. doi: 10.3390/ijerph182010969.
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.
数字无处不在,及时有效地支持数字认知方面的困难(例如,数学学习障碍(MLD))对其日常使用至关重要。迄今为止,仅提供了低疗效的认知为基础的干预措施。大量关于 MLD 的神经生物学数据增加了对大脑导向方法的兴趣。本研究方案的总体目标是为设计针对儿童和青少年 MLD 的基于大脑和基于证据的治疗方法提供科学依据。在这项双盲、受试者间、假对照、随机临床试验中,将对参与者进行经颅随机噪声刺激(tRNS)加认知训练。在基线(T0)、干预结束时(T1)、一周后(T2)和三个月后(T3)采集算术、神经心理学、心理和电生理测量值。我们预计 tRNS 加认知训练将显著改善 T1 时的算术测量值,以及每个随访时间点(T2、T3)的测量值,与安慰剂相比,而这种改善将与神经心理学、心理和电生理测量值的变化呈强正相关。我们坚信,这项临床试验将产生可靠和积极的结果,以加速对 MLD 的基于大脑的治疗方法的验证,这些方法有可能影响生活质量。