Clinical trial NCT05832060: Comparing the Efficacy of tDCS and tRNS to Improve Reading Skills in Children and Adolescents With Dyslexia
Official title: Comparing the Efficacy of tDCS and tRNS to Improve Reading Skills in Children and Adolescents With Dyslexia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Developmental Dyslexia
Keywords: Children
Adolescents
tRNS
transcranial random noise stimulation
tDCS
transcranial direct current stimulation
neurodevelopmental disorders
non-invasive brain stimulation
transcranial electrical stimulation
EEG
reading abilities
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

The investigator's overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in DD, based on the two most used brain stimulation techniques in pediatric population.

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: Text reading accuracy (Experimental reading task)
timeFrame: during procedure
Secondary outcomes:
measure: Text reading speed (Experimental reading task)
timeFrame: during procedure
measure: Experimental reading task: high-frequency word reading accuracy
timeFrame: during procedure
measure: Experimental reading task: high-frequency word reading speed
timeFrame: during procedure
measure: Experimental reading task: low-frequency word reading accuracy
timeFrame: during procedure
measure: Experimental reading task: low-frequency word reading speed
timeFrame: during procedure
measure: Experimental reading task: non-word reading accuracy
timeFrame: during procedure
measure: Experimental reading task: non-word reading speed
timeFrame: during procedure
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Bambino Gesù Hospital and Research Institute
Study officials:
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