Transcranial Direct Current Stimulation in the Treatment of Dyslexia.

NCT04244578 | Completed

• 1 other identifier: 201201X002931
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslexia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Non-word reading accuracy

  up to one month after the end of the intervention

• Word reading speed

  up to one month after the end of the intervention

• Word reading accuracy

  up to one month after the end of the intervention

• Text reading speed

  up to one month after the end of the intervention

• Text reading accuracy

  up to one month after the end of the intervention

Study Arms (2)

Active-Sham tDCS

EXPERIMENTAL

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; Device: Sham tDCS

Sham-Active tDCS

ACTIVE COMPARATOR

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; Device: Sham tDCS

Interventions

Active tDCS DEVICE

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.

Also known as: Brainstim Active tDCS

Active-Sham tDCS; Sham-Active tDCS

Sham tDCS DEVICE

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.

Also known as: Brainstim Sham tDCS

Active-Sham tDCS; Sham-Active tDCS

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents with dyslexia (DSM-5, APA 2013)
• IQ ≥ 85

You may not qualify if:

• 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;

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead

Study Sites (1)

Bambino Gesù Hospital and Research Institute

Roma, 00165, Italy

Location

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MeSH Terms

Conditions

Dyslexia; Specific Learning Disorder

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Clinical Psychologist

Study Record Dates

• First Submitted: January 25, 2020
• First Posted: January 28, 2020
• Study Start: May 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: February 1, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)