Restoring Neural Oscillatory Communication in Developmental Dyslexia

NCT05583136 | Completed

• 1 other identifier: NeOsReDy-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Developmental dyslexia (DD) is a multifactorial disorder that hampers the education of about 10% of individuals across cultures and is associated to both phonological and visual deficits. The latter have been linked to a deficit in the magnocellular-dorsal (M-D) visual stream, that has a critical role in guiding the activity of ventral visual stream areas where letters identity is extracted. Here, we will test the efficacy of transcranial alternate current stimulation (tACS) of the M-D stream combined with reading trainings in adult participants with DD, assessing the neurophysiological underpinnings of these new trainings with EEG and fMRI/DTI.

Conditions

Developmental Dyslexia

Outcome Measures

Primary Outcomes (1)

• Reading score

  Text, word and pseudowords reading score

  Pre-training, 1-7 days post-training, follow-up at 1 and 6 months

Study Arms (3)

Group DD1

EXPERIMENTAL

tACS + visuo-attentional training

Device: Parietal tACS combined with visuo-attentional training

Group DD2

ACTIVE COMPARATOR

Sham (placebo) tACS + visuo-attentional training

Device: Sham (placebo) tACS combined with visuo-attentional training

Group DD3

ACTIVE COMPARATOR

Sham (placebo) tACS + phonics training

Device: Sham (placebo) tACS combined with phonics training

Interventions

Parietal tACS combined with visuo-attentional training DEVICE

Parietal tACS combined with visuo-attentional training

Group DD1

Sham (placebo) tACS combined with visuo-attentional training DEVICE

Sham (placebo) tACS combined with visuo-attentional training

Group DD2

Sham (placebo) tACS combined with phonics training DEVICE

Sham (placebo) tACS combined with phonics training

Group DD3

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patient (age between 18 and 35)
• Official Diagnosis of Developmental Dyslexia (DD)
• Normal or corrected-to-normal vision and hearing
• Normal motor skills

You may not qualify if:

• Participants that cannot sign the consent form
• Participants unable to read or understand and correctly complete the procedures foreseen by the study
• Participants with a diagnosis or personal history of epilepsy or patients with a positive family history of epilepsy
• Pregnant or breastfeeding patients
• Participants with major psychiatric or neurological disorders and/or currently in psychopharmacological treatments.
• Participants with metal implants in the brain, pacemakers, brain stimulators, cochlear implants.
• Participants with claustrophobia (only for fMRI)

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

Study Sites (1)

Luca Ronconi

Milan, Italy, 20132, Italy

Location

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; 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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 17, 2022
• Study Start: December 14, 2021
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: January 27, 2025

Record last verified: 2022-10

Locations

IT (1)