Comparing the Efficacy of tDCS and tRNS to Improve Reading Skills in Children and Adolescents With Dyslexia

Bambino Gesù Hospital and Research Institute

Status: Invitation-only

Conditions: Developmental Dyslexia

Treatments: Device: Active tDCS; Device: Sham tRNS or tDCS; Device: Active tRNS

Study type: Interventional

Funder types: Other

Identifiers

NCT05832060

2639_OPBG_2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 6 patient groups

tDCS, tRNS, Sham

Experimental group

Description:

1. Active left anodal/right cathodal tDCS over TPC 2. Active tRNS over bilateral TPC 3. Sham tRNS or tDCS over bilateral TPC

Treatment:

Device: Active tDCS

Device: Active tRNS

Device: Sham tRNS or tDCS

tDCS, Sham, tRNS

Experimental group

Description:

1. Active left anodal/right cathodal tDCS over TPC 2. Sham tRNS or tDCS over bilateral TPC 3. Active tRNS over bilateral TPC

Treatment:

Device: Active tDCS

Device: Active tRNS

Device: Sham tRNS or tDCS

tRNS, tDCS, Sham

Experimental group

Description:

1. Active tRNS over bilateral TPC 2. Active left anodal/right cathodal tDCS over TPC 3. Sham tRNS or tDCS over bilateral TPC

Treatment:

Device: Active tDCS

Device: Active tRNS

Device: Sham tRNS or tDCS

tRNS, Sham, tDCS

Experimental group

Description:

1. Active tRNS over bilateral TPC 2. Sham tRNS or tDCS over bilateral TPC 3. Active left anodal/right cathodal tDCS over TPC

Treatment:

Device: Active tDCS

Device: Active tRNS

Device: Sham tRNS or tDCS

Sham, tDCS, tRNS

Experimental group

Description:

1. Sham tRNS or tDCS over bilateral TPC 2. Active left anodal/right cathodal tDCS over TPC 3. Active tRNS over bilateral TPC

Treatment:

Device: Active tDCS

Device: Active tRNS

Device: Sham tRNS or tDCS

Sham, tRNS, tDCS

Experimental group

Description:

1. Sham tRNS or tDCS over bilateral TPC 2. Active tRNS over bilateral TPC 3. Active left anodal/right cathodal tDCS over TPC

Treatment:

Device: Active tDCS

Device: Active tRNS

Device: Sham tRNS or tDCS