Transcranial Direct Current Stimulation in the Treatment of Dyslexia.

Dyslexia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04244578
• Other study ID #: 201201X002931
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: February 1, 2021

Study information

• Verified date: July 2021
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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;

Related Conditions & MeSH terms

• Dyslexia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Bambino Gesù Hospital and Research Institute	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Bambino Gesù Hospital and Research Institute

Country where clinical trial is conducted

Italy, 

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to one month after the end of the intervention
Secondary	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.	up to one month after the end of the intervention
Secondary	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.	up to one month after the end of the intervention
Secondary	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.	up to one month after the end of the intervention
Secondary	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.	up to one month after the end of the intervention
Secondary	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.	up to one month after the end of the intervention
Secondary	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.	up to one month after the end of the intervention
Secondary	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.	up to one month after the end of the intervention
Secondary	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.	up to one month after the end of the intervention
Secondary	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.	up to one month after the end of the intervention
Secondary	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.	up to one month after the end of the intervention