Restoring Neural Oscillatory Communication in Developmental Dyslexia

January 23, 2025 updated by: Luca Ronconi, IRCCS Ospedale San Raffaele

Restoring Neural Oscillatory Communication Between Dorsal and Ventral Visual Streams in Developmental Dyslexia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Luca Ronconi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group DD1
tACS + visuo-attentional training
Device: Parietal tACS combined with visuo-attentional training
Parietal tACS combined with visuo-attentional training
Active Comparator: Group DD2
Sham (placebo) tACS + visuo-attentional training
Device: Sham (placebo) tACS combined with visuo-attentional training
Sham (placebo) tACS combined with visuo-attentional training
Active Comparator: Group DD3
Sham (placebo) tACS + phonics training
Device: Sham (placebo) tACS combined with phonics training
Sham (placebo) tACS combined with phonics training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reading score
Time Frame: Pre-training, 1-7 days post-training, follow-up at 1 and 6 months
Text, word and pseudowords reading score
Pre-training, 1-7 days post-training, follow-up at 1 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Ospedale San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2021

Primary Completion (Actual)

December 23, 2024

Study Completion (Actual)

December 23, 2024

Study Registration Dates

First Submitted

October 7, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NeOsReDy-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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