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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Developmental Dyslexia
• Intervention / Treatment: Device: Active tDCS; Device: Active tRNS; Device: Sham tRNS or tDCS

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00165
    • Bambino Gesù Hospital and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tDCS, tRNS, Sham; Active left anodal/right cathodal tDCS over TPC; Active tRNS over bilateral TPC; Sham tRNS or tDCS over bilateral TPC	Device: Active tDCS; Active tDCS will be delivered over TPC for a stimulation session. The anodal electrode will be placed on the left TPC, T7/TP7 position according to the 10-20 International EEG 10-20 System for electrode placement. The cathodal electrode will be placed on the right TPC, T8/TP8 position. Intensity will be set at 1 mA, the duration of stimulation will be 20 min.; Device: Active tRNS; Active tRNS will be delivered to bilateral TPC for a stimulation session. The electrodes will be placed on the left and right TPC, respectively T7/TP7 and T8/TP8 position, at 0.75 mA (100-500 Hz) for 20 min.; Device: Sham tRNS or tDCS; Sham tRNS or tDCS will be delivered over bilateral TPC for a stimulation session. The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down without the participants awareness.
Experimental: tDCS, Sham, tRNS; Active left anodal/right cathodal tDCS over TPC; Sham tRNS or tDCS over bilateral TPC; Active tRNS over bilateral TPC	Device: Active tDCS; Active tDCS will be delivered over TPC for a stimulation session. The anodal electrode will be placed on the left TPC, T7/TP7 position according to the 10-20 International EEG 10-20 System for electrode placement. The cathodal electrode will be placed on the right TPC, T8/TP8 position. Intensity will be set at 1 mA, the duration of stimulation will be 20 min.; Device: Active tRNS; Active tRNS will be delivered to bilateral TPC for a stimulation session. The electrodes will be placed on the left and right TPC, respectively T7/TP7 and T8/TP8 position, at 0.75 mA (100-500 Hz) for 20 min.; Device: Sham tRNS or tDCS; Sham tRNS or tDCS will be delivered over bilateral TPC for a stimulation session. The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down without the participants awareness.
Experimental: tRNS, tDCS, Sham; Active tRNS over bilateral TPC; Active left anodal/right cathodal tDCS over TPC; Sham tRNS or tDCS over bilateral TPC	Device: Active tDCS; Active tDCS will be delivered over TPC for a stimulation session. The anodal electrode will be placed on the left TPC, T7/TP7 position according to the 10-20 International EEG 10-20 System for electrode placement. The cathodal electrode will be placed on the right TPC, T8/TP8 position. Intensity will be set at 1 mA, the duration of stimulation will be 20 min.; Device: Active tRNS; Active tRNS will be delivered to bilateral TPC for a stimulation session. The electrodes will be placed on the left and right TPC, respectively T7/TP7 and T8/TP8 position, at 0.75 mA (100-500 Hz) for 20 min.; Device: Sham tRNS or tDCS; Sham tRNS or tDCS will be delivered over bilateral TPC for a stimulation session. The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down without the participants awareness.
Experimental: tRNS, Sham, tDCS; Active tRNS over bilateral TPC; Sham tRNS or tDCS over bilateral TPC; Active left anodal/right cathodal tDCS over TPC	Device: Active tDCS; Active tDCS will be delivered over TPC for a stimulation session. The anodal electrode will be placed on the left TPC, T7/TP7 position according to the 10-20 International EEG 10-20 System for electrode placement. The cathodal electrode will be placed on the right TPC, T8/TP8 position. Intensity will be set at 1 mA, the duration of stimulation will be 20 min.; Device: Active tRNS; Active tRNS will be delivered to bilateral TPC for a stimulation session. The electrodes will be placed on the left and right TPC, respectively T7/TP7 and T8/TP8 position, at 0.75 mA (100-500 Hz) for 20 min.; Device: Sham tRNS or tDCS; Sham tRNS or tDCS will be delivered over bilateral TPC for a stimulation session. The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down without the participants awareness.
Experimental: Sham, tDCS, tRNS; Sham tRNS or tDCS over bilateral TPC; Active left anodal/right cathodal tDCS over TPC; Active tRNS over bilateral TPC	Device: Active tDCS; Active tDCS will be delivered over TPC for a stimulation session. The anodal electrode will be placed on the left TPC, T7/TP7 position according to the 10-20 International EEG 10-20 System for electrode placement. The cathodal electrode will be placed on the right TPC, T8/TP8 position. Intensity will be set at 1 mA, the duration of stimulation will be 20 min.; Device: Active tRNS; Active tRNS will be delivered to bilateral TPC for a stimulation session. The electrodes will be placed on the left and right TPC, respectively T7/TP7 and T8/TP8 position, at 0.75 mA (100-500 Hz) for 20 min.; Device: Sham tRNS or tDCS; Sham tRNS or tDCS will be delivered over bilateral TPC for a stimulation session. The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down without the participants awareness.
Experimental: Sham, tRNS, tDCS; Sham tRNS or tDCS over bilateral TPC; Active tRNS over bilateral TPC; Active left anodal/right cathodal tDCS over TPC	Device: Active tDCS; Active tDCS will be delivered over TPC for a stimulation session. The anodal electrode will be placed on the left TPC, T7/TP7 position according to the 10-20 International EEG 10-20 System for electrode placement. The cathodal electrode will be placed on the right TPC, T8/TP8 position. Intensity will be set at 1 mA, the duration of stimulation will be 20 min.; Device: Active tRNS; Active tRNS will be delivered to bilateral TPC for a stimulation session. The electrodes will be placed on the left and right TPC, respectively T7/TP7 and T8/TP8 position, at 0.75 mA (100-500 Hz) for 20 min.; Device: Sham tRNS or tDCS; Sham tRNS or tDCS will be delivered over bilateral TPC for a stimulation session. The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down without the participants awareness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Text reading accuracy (Experimental reading task)	Change from baseline in text reading accuracy during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Text reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experimental reading task: high-frequency word reading accuracy	Change from baseline in high-frequency word reading accuracy during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. High-frequency word reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.	during procedure
Experimental reading task: high-frequency word reading speed	Change from baseline in high-frequency word reading speed during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. High-frequency word reading speed is considered as the syllables/seconds ratio and calculated dividing the total number of syllables pronounced by the total time spent to complete the reading (in seconds).	during procedure
Experimental reading task: low-frequency word reading accuracy	Change from baseline in low-frequency word reading accuracy during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Low-frequency word reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.	during procedure
Experimental reading task: low-frequency word reading speed	Change from baseline in low-frequency word reading speed during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Low-frequency word reading speed is considered as the syllables/seconds ratio and calculated dividing the total number of syllables pronounced by the total time spent to complete the reading (in seconds).	during procedure
Experimental reading task: non-word reading accuracy	Change from baseline in non-word reading accuracy during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Non-word reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.	during procedure
Experimental reading task: non-word reading speed	Change from baseline in non-word reading speed during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Non-word reading speed is considered as the syllables/seconds ratio and calculated dividing the total number of syllables pronounced by the total time spent to complete the reading (in seconds).	during procedure
Text reading speed (Experimental reading task)	Change from baseline in text reading speed during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Text reading speed is considered as the syllables/seconds ratio and calculated dividing the total number of syllables pronounced by the total time spent to complete the reading (in seconds).	during procedure

Collaborators and Investigators

• Sponsor: Bambino Gesù Hospital and Research Institute

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; tDCS; transcranial direct current stimulation; Children; EEG; non-invasive brain stimulation; transcranial random noise stimulation; tRNS; transcranial electrical stimulation; neurodevelopmental disorders; reading abilities
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Dyslexia
• Other Study ID Numbers: 2639_OPBG_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No