Improving Math Deficits in Children With Dyscalculia by tRNS: a Randomized, Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Number Line
研究概览
简要总结
The present study grounds on the absence of evidence-based treatment in individuals with developmental dyscalculia (DD). At this topic, the present study will explore the potential effect of transcranial random noise stimulation (tRNS) over dorsolateral prefrontal cortex (DLPFC) or posterior parietal cortex (PPC), cerebral areas usually disrupted in individuals with DD, in addition to a usual treatment such as cognitive training.
Therefore, the investigators hypothesized that active tRNS over DLPFC or PPC combined to cognitive training will boost math and math-related skills in children and adolescents with DD, modulating theta/beta ratio around stimulated cerebral network. On the contrary, sham tRNS (placebo) over DLPFC or PPC combined to cognitive training will not have significant effect in improving math skills. Further, both active and sham tRNS combined to cognitive training will be safe and well tolerated.
详细描述
The study design is randomized stratified, double blind, placebo-controlled.
A group of children and adolescents with DD will be selected and randomly assigned to three different conditions: 1. tRNS over bilateral DLPFC + cognitive training (Brainstim DLPFC); 2. tRNS over bilateral PPC (Brainstim PPC) + cognitive training; 3. sham tRNS (bilateral DLPFC/bilateral PPC; Brainstim Sham) + cognitive training.
In this project, the investigators will work to understand whether a brain-based intervention, with the use of tRNS, combined to a usual treatment can improve the outcome of individual with DD.
The protocol will allow the investigators to:
- testing the critical role of two brain regions (DLPFC or PPC) usually involved in numerical abilities and disrupted in individuals with DD;
- examining the neural changes (using EEG recordings) due to cognitive training without tRNS (Brainstim Sham) and with tRNS (Brainstim DLPFC; Brainstim PPC);
- predicting training outcomes based on math-related skills;
- testing the critical role of neural markers at developmental ages using a closed-loop tRNS to improve learning and cognitive outcomes from the training;
- investigating the safety and tolerability of tRNS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents with DD (Total Quotient of BDE-2 ≤ 70)
排除标准
- •Having a comorbidity with an important medical conditions;
- •Having neurological diseases;
- •Having Epilepsy o family history of epilepsy;
- •Receiving a treatment for DD in the previous three months before the baseline screening;
结局指标
主要结局
Number Line
时间窗: immediately after the intervention, one week and three months after the intervention
The proportion of patients with change of at least 1 SD in the "number line task" of the Diagnostic battery for Dyscalculia (BDE 2, Biancardi et al., 2016) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
次要结局
- Total Quotient(immediately after the intervention, one week and three months after the intervention)
- Geometric Puzzle(immediately after the intervention, one week and three months after the intervention)
- Mental multiplications and additions(immediately after the intervention, one week and three months after the intervention)
- Math computerized task(immediately after the intervention, one week and three months after the intervention)
- Sleep quality(immediately after the intervention, one week and three months after the intervention)
- Incidence of Treatment-Emergent Adverse Events [Safety and tolerability](immediately after the intervention, one week and three months after the intervention)
- Tempo Test Rekenen(immediately after the intervention, one week and three months after the intervention)
- Motivation and study strategies Questionnaire(immediately after the intervention, one week and three months after the intervention)
- Math Anxiety Questionnaire(immediately after the intervention, one week and three months after the intervention)
- Numerical Quotient(immediately after the intervention, one week and three months after the intervention)
- Calculation Quotient(immediately after the intervention, one week and three months after the intervention)
- Number Sense Quotient(immediately after the intervention, one week and three months after the intervention)
- Parental stress(immediately after the intervention, one week and three months after the intervention)
- Emotional/behavioural problems(immediately after the intervention, one week and three months after the intervention)
- Math improvement at school(three months after the intervention)
- Theta/Beta ratio(immediately after the intervention, one week and three months after the intervention)
- Verbal and visuo-spatial working-memory(immediately after the intervention, one week and three months after the intervention)
研究者
Deny Menghini
Clinical Psychologist
Bambino Gesù Hospital and Research Institute