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RecruitingNCT06186882GedysUpdated Jan 2, 2024

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

An interventional study of Action Video-Game in Reading Disorder, sponsored by IRCCS Eugenio Medea. Recruiting at 1 site in Italy. Open to participants aged 5 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-02.

Sponsored by IRCCS Eugenio Medea · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as recruiting.
  • Registered 7 months after the study started (first participant enrolled Apr 2023, registered Nov 2023).
  • Started Apr 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
5 Years to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Reading Disorder

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03

In context

Dyslexia

127 studies on the registry are indexed under Dyslexia; 27 are open to participants now.

This study's planned enrollment of 60 is below the median of 71 across 106 interventional studies indexed under Dyslexia.

Browse Dyslexia studies →

Lead sponsor

IRCCS Eugenio Medea is the lead sponsor of 108 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • intelligence quotient below the average range,
  • presence of counter indications for magnetic resonance acquisition,
  • previous diagnosis of any neurodevelopmental disorders.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    ENVIRONMENTAL STIMULATION

    Behavioral: Action Video-Game

Interventions

  • BehavioralAction 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.

06

What researchers measure

Primary outcomes

  1. Short-term memory

    Short-term memory - assessed by the Single Digit Forward Span, Single Digit Backward Span. Measures obtained: Z scores age-corrected.

    Time frame: 3 years

  2. Phonological awareness

    Phonological awareness - assessed by the nonword repetition test. Measures obtained: Z scores age-corrected.

    Time frame: 3 years

  3. Rapid automatized naming

    Rapid automatized naming - assessed by the RAN test. Measures obtained: Z scores age-corrected.

    Time frame: 3 years

  4. Reading skills

    Reading skills - assessed by single unrelated words and pseudo-words reading tests. Measures obtained: Z scores age-corrected.

    Time frame: 3 years

  5. Visual attention

    Visual attention - assessed by a computer-based visual attention task

    Time frame: 3 years

  6. Visual motion processing

    Visual motion processing - assessed by Coherent dot motion task

    Time frame: 3 years

  7. measurement of neurotransmitters

    in vivo measures of neurotransmitters including glutamate and gamma-Aminobutyric acid magnetic resonance spectroscopy

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06186882
Collaborators
Università degli studi di Bergamo
Responsible party
Sponsor
First posted
Jan 2, 2024
Start date
Apr 30, 2023
Primary completion
Apr 30, 2026 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Jan 2, 2024

Study contacts

Sara Mascheretti
Contact
sara.mascheretti@lanostrafamiglia.it
031877895

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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