Transcranial Direct Current Stimulation in the Treatment of Dyslexia.
Condition: Dyslexia
MeSH terms: Dyslexia
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

        1. Testing the efficacy of stand-alone tDCS in enhancing reading in individuals with
           dyslexia;

        2. Testing the critical role of brain regions (parieto-occipital areas) usually involved in
           reading and disrupted in dyslexia;

        3. Predicting outcomes based on reading-related skills;

        4. Investigating the safety and tolerability of tDCS;

      The overarching goal is to provide a scientific foundation for devising new rehabilitation
      strategies in dyslexia.
    

Intervention name(s): Active tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): Active tDCS will be delivered to parieto-occipital areas for five consecutive days. tDCS will be delivered by a battery driven, direct current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands. The electrodes will be placed on the left (anodal) and right (cathodal) parieto-occipital areas, PO7 and PO8 position according to the 10-20 international EEG system for electrode placement. Stimulation intensity will be set at 1 milliampere (mA), the duration of stimulation will be 20 min.; Sham tDCS will be delivered to parieto-occipital areas for five consecutive days. tDCS will be delivered by a battery driven, direct current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands. The electrodes will be placed on the left (anodal) and right (cathodal) parieto-occipital areas, PO7 and PO8 position according to the 10-20 international EEG system for electrode placement. Stimulation intensity will be set at 1 milliampere (mA), but the current will be applied for 30 s and will be ramped down without the participants awareness.
Other intervention name(s): Brainstim Active tDCS; Brainstim Sham tDCS
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tDCS; transcranial direct current stimulation; transcranial electric stimulation; developmental dyslexia; specific learning disorders; treatment