Gene x Environment Interplay in Developmental Dyslexia Treatment: A Round-trip Translation Between Humans and Animal (Gedys)

December 15, 2023 updated by: IRCCS Eugenio Medea
Developmental dyslexia affects 7% of school-age children (Male:Female ratio of 1.5:1) and incurs disadvantages in education and occupation. Scientific progress concerning the etiology of developmental dyslexia evidenced the complex gene-environment interaction. The DCDC2-READ1 deletion associates with reading skills and affects the magnocellular-dorsal stream in humans and animals. DCDC2 modifies neural activity within the excitatory pathways. The magnocellular-dorsal stream mediates the function of the attention network. Difficulties in spatial and temporal attention shifting impair letter-to-speech sound integration increasing neural noise. Action video games improve the efficiency of the magnocellular-dorsal stream. The aim of this cutting-edge, round trip translation study is threefold: 1.to unravel new insights behind the pathophysiology of developmental dyslexia, 2. to assess gene-environment interaction effects on developmental dyslexia endophenotypes, and 3. to identify useful clues to foster the identification of new, personalized treatments.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Locations

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • 5-years old pre-readers,
  • normal intelligence quotient,
  • no main counter indications for magnetic resonance acquisition,
  • no previous diagnosis of any neurodevelopmental disorders.

Exclusion Criteria:

  • intelligence quotient below the average range,
  • presence of counter indications for magnetic resonance acquisition,
  • previous diagnosis of any neurodevelopmental disorders.

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ENVIRONMENTAL STIMULATION
Behavioral: Action Video-Game
Thanks to their specific characteristics (presentation of multiple peripheral, rapidly moving, spatio-temporally unpredictable stimuli), Action Video-Games improve reading skills through their effects on the Magnocellular-Dorsal stream. Training will consist of 20 days of Action Video-Games sessions of 1 hour each, three times per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term memory
Time Frame: 3 years
Short-term memory - assessed by the Single Digit Forward Span, Single Digit Backward Span. Measures obtained: Z scores age-corrected.
3 years
Phonological awareness
Time Frame: 3 years
Phonological awareness - assessed by the nonword repetition test. Measures obtained: Z scores age-corrected.
3 years
Rapid automatized naming
Time Frame: 3 years
Rapid automatized naming - assessed by the RAN test. Measures obtained: Z scores age-corrected.
3 years
Reading skills
Time Frame: 3 years
Reading skills - assessed by single unrelated words and pseudo-words reading tests. Measures obtained: Z scores age-corrected.
3 years
Visual attention
Time Frame: 3 years
Visual attention - assessed by a computer-based visual attention task
3 years
Visual motion processing
Time Frame: 3 years
Visual motion processing - assessed by Coherent dot motion task
3 years
measurement of neurotransmitters
Time Frame: 3 years
in vivo measures of neurotransmitters including glutamate and gamma-Aminobutyric acid magnetic resonance spectroscopy
3 years

Collaborators and Investigators

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

Sponsor

IRCCS Eugenio Medea

Collaborators

Università degli studi di Bergamo

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)

April 30, 2023

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Estimated)

January 1, 2024

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR-2021-12375102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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