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Transcranial Direct Current Stimulation in the Treatment of Dyslexia.

B

Bambino Gesù Hospital and Research Institute

Status

Completed

Conditions

Dyslexia

Treatments

Device: Active tDCS
Device: Sham tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT04244578
201201X002931

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

9 to 18 years old

Volunteers

No 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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

28 participants in 2 patient groups

Active-Sham tDCS
Experimental group
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.
Treatment:
Device: Sham tDCS
Device: Active tDCS
Sham-Active tDCS
Active Comparator group
Description:
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.
Treatment:
Device: Sham tDCS
Device: Active tDCS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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