Comparing the Efficacy of tDCS and tRNS to Improve Reading Skills in Children and Adolescents With Dyslexia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Text reading accuracy (Experimental reading task)
研究概览
简要总结
The present study grounds on the absence of evidence-based treatment in individuals with developmental dyslexia (DD). At this topic, the present study will explore the potential effect of transcranial random noise stimulation (tRNS) and transcranial direct current stimulation (tDCS) over bilateral temporo-parietal cortex (TPC), cerebral areas usually disrupted in individuals with DD.
The investigators hypothesized that active tRNS and tDCS over TPC will boost reading skills in children and adolescents with DD. On the contrary, sham (placebo) tRNS and tDCS over TPC will not have significant effect in improving reading skills. Further, both active and sham tRNS and tDCS will be safe and well tolerated.
详细描述
The study design is within-subject, randomized stratified, double blind, placebo-controlled.
A group of children and adolescents with DD will be selected and exposed to three different conditions with an interval-session of at least 6 days: 1. tRNS over bilateral TPC; 2. anodal tDCS over left TPC (cathode over right TPC); 3. sham tRNS or tDCS. During stimulation (both real and sham), participants will undergo a concomitant reading task.
In this project, the investigators will work to understand whether a brain-based intervention, with the use of tRNS and tDCS, can improve the outcome of individuals with DD.
The protocol will allow the investigators to:
- comparing the efficacy of tDCS and tRNS over TPC in improving reading abilities,
- comparing the safety and tolerability of tDCS and tRNS in children and adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children and adolescents with dyslexia (DSM-5, APA 2013)
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 dyslexia in the previous three months before the baseline screening.
研究组 & 干预措施
tDCS, tRNS, Sham
- Active left anodal/right cathodal tDCS over TPC
- Active tRNS over bilateral TPC
- Sham tRNS or tDCS over bilateral TPC
干预措施: Active tDCS (Device)
tDCS, tRNS, Sham
- Active left anodal/right cathodal tDCS over TPC
- Active tRNS over bilateral TPC
- Sham tRNS or tDCS over bilateral TPC
干预措施: Active tRNS (Device)
tDCS, tRNS, Sham
- Active left anodal/right cathodal tDCS over TPC
- Active tRNS over bilateral TPC
- Sham tRNS or tDCS over bilateral TPC
干预措施: Sham tRNS or tDCS (Device)
tDCS, Sham, tRNS
- Active left anodal/right cathodal tDCS over TPC
- Sham tRNS or tDCS over bilateral TPC
- Active tRNS over bilateral TPC
干预措施: Active tDCS (Device)
tDCS, Sham, tRNS
- Active left anodal/right cathodal tDCS over TPC
- Sham tRNS or tDCS over bilateral TPC
- Active tRNS over bilateral TPC
干预措施: Active tRNS (Device)
tDCS, Sham, tRNS
- Active left anodal/right cathodal tDCS over TPC
- Sham tRNS or tDCS over bilateral TPC
- Active tRNS over bilateral TPC
干预措施: Sham tRNS or tDCS (Device)
tRNS, tDCS, Sham
- Active tRNS over bilateral TPC
- Active left anodal/right cathodal tDCS over TPC
- Sham tRNS or tDCS over bilateral TPC
干预措施: Active tDCS (Device)
tRNS, tDCS, Sham
- Active tRNS over bilateral TPC
- Active left anodal/right cathodal tDCS over TPC
- Sham tRNS or tDCS over bilateral TPC
干预措施: Active tRNS (Device)
tRNS, tDCS, Sham
- Active tRNS over bilateral TPC
- Active left anodal/right cathodal tDCS over TPC
- Sham tRNS or tDCS over bilateral TPC
干预措施: Sham tRNS or tDCS (Device)
tRNS, Sham, tDCS
- Active tRNS over bilateral TPC
- Sham tRNS or tDCS over bilateral TPC
- Active left anodal/right cathodal tDCS over TPC
干预措施: Active tDCS (Device)
tRNS, Sham, tDCS
- Active tRNS over bilateral TPC
- Sham tRNS or tDCS over bilateral TPC
- Active left anodal/right cathodal tDCS over TPC
干预措施: Active tRNS (Device)
tRNS, Sham, tDCS
- Active tRNS over bilateral TPC
- Sham tRNS or tDCS over bilateral TPC
- Active left anodal/right cathodal tDCS over TPC
干预措施: Sham tRNS or tDCS (Device)
Sham, tDCS, tRNS
- Sham tRNS or tDCS over bilateral TPC
- Active left anodal/right cathodal tDCS over TPC
- Active tRNS over bilateral TPC
干预措施: Active tDCS (Device)
Sham, tDCS, tRNS
- Sham tRNS or tDCS over bilateral TPC
- Active left anodal/right cathodal tDCS over TPC
- Active tRNS over bilateral TPC
干预措施: Active tRNS (Device)
Sham, tDCS, tRNS
- Sham tRNS or tDCS over bilateral TPC
- Active left anodal/right cathodal tDCS over TPC
- Active tRNS over bilateral TPC
干预措施: Sham tRNS or tDCS (Device)
Sham, tRNS, tDCS
- Sham tRNS or tDCS over bilateral TPC
- Active tRNS over bilateral TPC
- Active left anodal/right cathodal tDCS over TPC
干预措施: Active tDCS (Device)
Sham, tRNS, tDCS
- Sham tRNS or tDCS over bilateral TPC
- Active tRNS over bilateral TPC
- Active left anodal/right cathodal tDCS over TPC
干预措施: Active tRNS (Device)
Sham, tRNS, tDCS
- Sham tRNS or tDCS over bilateral TPC
- Active tRNS over bilateral TPC
- Active left anodal/right cathodal tDCS over TPC
干预措施: Sham tRNS or tDCS (Device)
结局指标
主要结局
Text reading accuracy (Experimental reading task)
时间窗: during procedure
Change from baseline in text reading accuracy during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Text reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.
次要结局
- Experimental reading task: low-frequency word reading accuracy(during procedure)
- Experimental reading task: high-frequency word reading accuracy(during procedure)
- Text reading speed (Experimental reading task)(during procedure)
- Experimental reading task: non-word reading speed(during procedure)
- Experimental reading task: non-word reading accuracy(during procedure)
- Experimental reading task: high-frequency word reading speed(during procedure)
- Experimental reading task: low-frequency word reading speed(during procedure)
研究者
Deny Menghini
Head of Psychology Unit
Bambino Gesù Hospital and Research Institute