Clinical trial NCT04244578: Transcranial Direct Current Stimulation in the Treatment of Dyslexia.
Official title: Transcranial Direct Current Stimulation in the Treatment of Dyslexia: a Randomized Double-blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslexia
Keywords: tDCS
transcranial direct current stimulation
transcranial electric stimulation
developmental dyslexia
specific learning disorders
treatment
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 28
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Children and adolescents with dyslexia (DSM-5, APA 2013)
* IQ ≥ 85

Exclusion Criteria:

* 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;

Primary outcomes:
measure: Non-word reading speed
timeFrame: up to one month after the end of the intervention
Secondary outcomes:
measure: Non-word reading accuracy
timeFrame: up to one month after the end of the intervention
measure: Word reading speed
timeFrame: up to one month after the end of the intervention
measure: Word reading accuracy
timeFrame: up to one month after the end of the intervention
measure: Text reading speed
timeFrame: up to one month after the end of the intervention
measure: Text reading accuracy
timeFrame: up to one month after the end of the intervention
measure: Verbal and visuo-spatial n-back
timeFrame: up to one month after the end of the intervention
measure: Phoneme Blending
timeFrame: up to one month after the end of the intervention
measure: Rapid Automatized Naming of color and letters
timeFrame: up to one month after the end of the intervention
measure: Lexical Decision
timeFrame: up to one month after the end of the intervention
measure: Questionnaire of safety and tolerability (Questionnaire of adverse effect)
timeFrame: up to one month after the end of the intervention
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Bambino Gesù Hospital and Research Institute
Study officials:
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