Transcranial Direct Current Stimulation in the Treatment of Dyslexia.

July 19, 2021 updated by: Deny Menghini, Bambino Gesù Hospital and Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. Testing the efficacy of stand-alone tDCS in enhancing reading in individuals with dyslexia;
  2. Testing the critical role of brain regions (parieto-occipital areas) usually involved in reading and disrupted in dyslexia;
  3. Predicting outcomes based on reading-related skills;
  4. Investigating the safety and tolerability of tDCS;

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

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active-Sham tDCS
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.
Device: Active tDCS
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
Device: Sham tDCS
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
Active Comparator: Sham-Active tDCS

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.
Device: Active tDCS
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
Device: Sham tDCS
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to one month after the end of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to one month after the end of the intervention
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.
up to one month after the end of the intervention
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.
up to one month after the end of the intervention
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.
up to one month after the end of the intervention
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.
up to one month after the end of the intervention
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.
up to one month after the end of the intervention
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.
up to one month after the end of the intervention
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.
up to one month after the end of the intervention
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.
up to one month after the end of the intervention
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.
up to one month after the end of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bambino Gesù Hospital and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

January 25, 2020

First Submitted That Met QC Criteria

January 25, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201201X002931

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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