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

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: Reading Disorder
• Intervention / Treatment: Behavioral: Action Video-Game

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Mascheretti; Phone Number: 031877895; Email: sara.mascheretti@lanostrafamiglia.it

Study Locations

• Italy
  • LC
    • Bosisio Parini, LC, Italy, 23842
      • Recruiting
      • Scientific Institute IRCCS E Medea
      • Contact: Sara Mascheretti; Phone Number: 031877985; Email: sara.mascheretti@lanostrafamiglia.it

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea
• Collaborators: Università degli studi di Bergamo

Study record dates

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: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Dyslexia
• 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