NCT04244578

Transcranial Direct Current Stimulation in the Treatment of Dyslexia.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Bambino Gesù Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 9 Years – 18 Years
• Healthy volunteers: Not accepted

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: 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.

Conditions

• Dyslexia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2020-09-01
• Completion: 2021-02-01
• First posted: 2020-01-28
• Last updated: 2021-07-23

Locations

1 site across 1 country: Italy