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Transcranial Direct Current Stimulation in the Treatment of Dyslexia.

Primary Purpose

Dyslexia

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Active tDCS

Sham tDCS

About this trial

This is an interventional treatment trial for Dyslexia focused on measuring tDCS, transcranial direct current stimulation, transcranial electric stimulation, developmental dyslexia, specific learning disorders, treatment

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesDoes not accept 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;

Sites / Locations

Bambino Gesù Hospital and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active-Sham tDCS

Sham-Active tDCS

Arm Description

Each tDCS sessions will be delivered for 5 days for a total of non consecutive two weeks. The first session will be active tDCS and two months after, a sham tDCS will follow.

Each tDCS sessions (sham tDCS and active tDCS) will be delivered for 5 days for a total of non consecutive two weeks. The first session will be sham tDCS and two months after, an active tDCS will follow.

Outcomes

Primary Outcome Measures

Non-word reading speed

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 Outcome Measures

Non-word reading accuracy

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.

Word reading speed

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.

Word reading accuracy

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.

Text reading speed

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.

Text reading accuracy

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.

Verbal and visuo-spatial n-back

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.

Phoneme Blending

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.

Rapid Automatized Naming of color and letters

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.

Lexical Decision

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.

Questionnaire of safety and tolerability (Questionnaire of adverse effect)

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.

Full Information

NCT ID

NCT04244578

First Posted

January 25, 2020

Last Updated

July 19, 2021

Sponsor

Bambino Gesù Hospital and Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04244578

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

May 1, 2016 (Actual)

Primary Completion Date

September 1, 2020 (Actual)

Study Completion Date

February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bambino Gesù Hospital and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslexia

Keywords

tDCS, transcranial direct current stimulation, transcranial electric stimulation, developmental dyslexia, specific learning disorders, treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active-Sham tDCS

Arm Type

Experimental

Arm Description

Each tDCS sessions will be delivered for 5 days for a total of non consecutive two weeks. The first session will be active tDCS and two months after, a sham tDCS will follow.

Arm Title

Sham-Active tDCS

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Active tDCS

Other Intervention Name(s)

Brainstim Active tDCS

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham tDCS

Other Intervention Name(s)

Brainstim Sham tDCS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Non-word reading speed

Description

Time Frame

up to one month after the end of the intervention

Secondary Outcome Measure Information:

Title

Non-word reading accuracy

Description

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.

Time Frame

up to one month after the end of the intervention

Title

Word reading speed

Description

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.

Time Frame

up to one month after the end of the intervention

Title

Word reading accuracy

Description

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.

Time Frame

up to one month after the end of the intervention

Title

Text reading speed

Description

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.

Time Frame

up to one month after the end of the intervention

Title

Text reading accuracy

Description

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.

Time Frame

up to one month after the end of the intervention

Title

Verbal and visuo-spatial n-back

Description

Time Frame

up to one month after the end of the intervention

Title

Phoneme Blending

Description

Time Frame

up to one month after the end of the intervention

Title

Rapid Automatized Naming of color and letters

Description

Time Frame

up to one month after the end of the intervention

Title

Lexical Decision

Description

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.

Time Frame

up to one month after the end of the intervention

Title

Questionnaire of safety and tolerability (Questionnaire of adverse effect)

Description

Time Frame

up to one month after the end of the intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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;

Facility Information:

Facility Name

Bambino Gesù Hospital and Research Institute

City

Roma

ZIP/Postal Code

00165

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

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Transcranial Direct Current Stimulation in the Treatment of Dyslexia.

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