Transcranial Direct Current Stimulation in the Treatment of Dyslexia: a Randomized Double-blind Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Non-word reading speed
研究概览
简要总结
The present study grounds on the absence of evidence-based treatment in individuals with dyslexia. At this topic, the present study will explore the potential effect of transcranial direct current stimulation (tDCS) over parieto-occipital brain regions, cerebral areas usually disrupted in individuals with dyslexia. tDCS will be administered without concomitantly training.
Therefore, the investigators hypothesized that active tDCS over parieto-occipital areas will enhance reading skills in children and adolescents with dyslexia. On the contrary, sham tDCS (placebo) over parieto-occipital areas will not have significant effect on reading. Further, both active and sham tDCS will be safe and well-tolerated.
详细描述
The study design is randomized stratified, cross-over, double-blind, placebo-controlled.
Children and adolescents with dyslexia will be selected and randomly assigned to two different groups: 1. Active tDCS over parieto-occipital areas + sham tDCS over parieto-occipital areas (Active-Sham tDCS); 2. Sham tDCS over parieto-occipital areas + active tDCS over parieto-occipital areas (Sham-Active tDCS).
In this project, the investigators will work to understand whether a brain-based intervention, with the use of tDCS without combined training, can enhance reading in individuals with dyslexia.
The protocol will allow the investigators to:
- Testing the efficacy of stand-alone tDCS in enhancing reading in individuals with dyslexia;
- Testing the critical role of brain regions (parieto-occipital areas) usually involved in reading and disrupted in dyslexia;
- Predicting outcomes based on reading-related skills;
- Investigating the safety and tolerability of tDCS;
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
Active-Sham tDCS
Each tDCS sessions will be delivered for 5 days for a total of non consecutive two weeks. The first session will be active tDCS and two months after, a sham tDCS will follow.
干预措施: Active tDCS (Device)
Active-Sham tDCS
Each tDCS sessions will be delivered for 5 days for a total of non consecutive two weeks. The first session will be active tDCS and two months after, a sham tDCS will follow.
干预措施: Sham tDCS (Device)
Sham-Active tDCS
Each tDCS sessions (sham tDCS and active tDCS) will be delivered for 5 days for a total of non consecutive two weeks.
The first session will be sham tDCS and two months after, an active tDCS will follow.
干预措施: Active tDCS (Device)
Sham-Active tDCS
Each tDCS sessions (sham tDCS and active tDCS) will be delivered for 5 days for a total of non consecutive two weeks.
The first session will be sham tDCS and two months after, an active tDCS will follow.
干预措施: Sham tDCS (Device)
结局指标
主要结局
Non-word reading speed
时间窗: up to one month after the end of the intervention
The proportion of patients with change of at least 0.06 sill/sec in the non-word reading speed following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.
次要结局
- Text reading speed(up to one month after the end of the intervention)
- Verbal and visuo-spatial n-back(up to one month after the end of the intervention)
- Word reading speed(up to one month after the end of the intervention)
- Word reading accuracy(up to one month after the end of the intervention)
- Questionnaire of safety and tolerability (Questionnaire of adverse effect)(up to one month after the end of the intervention)
- Rapid Automatized Naming of color and letters(up to one month after the end of the intervention)
- Lexical Decision(up to one month after the end of the intervention)
- Non-word reading accuracy(up to one month after the end of the intervention)
- Text reading accuracy(up to one month after the end of the intervention)
- Phoneme Blending(up to one month after the end of the intervention)
研究者
Deny Menghini
PhD, Clinical Psychologist
Bambino Gesù Hospital and Research Institute