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Completed

NCT Number: NCT04244578

Transcranial Direct Current Stimulation in the Treatment of Dyslexia.

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.

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Key information

Conditions

Dyslexia Communication Disorders Language Disorders Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Specific Learning Disorder

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bambino Gesù Hospital and Research Institute

Roma, 00165, Italy

About this study

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;

The overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in dyslexia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

active tDCS

Device

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.

Other names: Brainstim Active tDCS

Sham tDCS

Device

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 names: Brainstim Sham tDCS

Primary outcomes

  1. Non-word reading speed

    Time frame: 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.

Secondary outcomes

  1. Non-word reading accuracy

    Time frame: up to one month after the end of the intervention

    The proportion of patients with change in the non-word reading accuracy following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.

  2. Word reading speed

    Time frame: up to one month after the end of the intervention

    The proportion of patients with change in the word reading speed following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.

  3. Word reading accuracy

    Time frame: up to one month after the end of the intervention

    The proportion of patients with change in the word reading accuracy following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.

  4. Text reading speed

    Time frame: up to one month after the end of the intervention

    The proportion of patients with change in the text reading speed following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.

  5. Text reading accuracy

    Time frame: up to one month after the end of the intervention

    The proportion of patients with change in the text reading accuracy following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.

  6. Verbal and visuo-spatial n-back

    Time frame: up to one month after the end of the intervention

    The proportion of patients with change in the index of verbal and visuo-spatial working memory (more score means better outcome) following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.

  7. Phoneme Blending

    Time frame: up to one month after the end of the intervention

    The proportion of patients with change in the index of phoneme blending (more score means better outcome) following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.

  8. Rapid Automatized Naming of color and letters

    Time frame: up to one month after the end of the intervention

    The proportion of patients with change in the accuracy and speed of Rapid Automatized Naming of color and letters following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.

  9. Lexical Decision

    Time frame: up to one month after the end of the intervention

    The proportion of patients with change in the accuracy and speed of Lexical decision following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.

  10. Questionnaire of safety and tolerability (Questionnaire of adverse effect)

    Time frame: up to one month after the end of the intervention

    The proportion of patients with change in the questionnaire of safety and tolerability (Questionnaire of adverse effect; Brunoni et al., 2011) following Active tDCS sessions will be the same than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.

Sponsors and collaborators

Lead sponsor

Bambino Gesù Hospital and Research Institute

Other

Registry information

Official study title

Transcranial Direct Current Stimulation in the Treatment of Dyslexia: a Randomized Double-blind Study.

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Jan 28, 2020
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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