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

NCT06186882 | Recruiting

• 1 other identifier: GR-2021-12375102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Reading Disorder

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

ENVIRONMENTAL STIMULATION

EXPERIMENTAL

Behavioral: Action Video-Game

Interventions

Action Video-Game BEHAVIORAL

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.

ENVIRONMENTAL STIMULATION

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• Università degli studi di Bergamo: collaborator

Study Sites (1)

Scientific Institute IRCCS E Medea

Bosisio Parini, LC, 23842, Italy

RECRUITING

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

Central Study Contacts

Sara Mascheretti

CONTACT

031877895; sara.mascheretti@lanostrafamiglia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: January 2, 2024
• Study Start: April 30, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)