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

Reading Disorder Clinical Trial

— Gedys  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186882
• Other study ID #: GR-2021-12375102
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: December 2023
• Source: IRCCS Eugenio Medea
• Contact: Sara Mascheretti
• Phone: 031877895
• Email: sara.mascheretti[@]lanostrafamiglia.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslexia
• Reading Disorder

Intervention

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.

Locations

Country	Name	City	State
Italy	Scientific Institute IRCCS E Medea	Bosisio Parini	LC

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea	Università degli studi di Bergamo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Phonological awareness	Phonological awareness - assessed by the nonword repetition test. Measures obtained: Z scores age-corrected.	3 years
Primary	Rapid automatized naming	Rapid automatized naming - assessed by the RAN test. Measures obtained: Z scores age-corrected.	3 years
Primary	Reading skills	Reading skills - assessed by single unrelated words and pseudo-words reading tests. Measures obtained: Z scores age-corrected.	3 years
Primary	Visual attention	Visual attention - assessed by a computer-based visual attention task	3 years
Primary	Visual motion processing	Visual motion processing - assessed by Coherent dot motion task	3 years
Primary	measurement of neurotransmitters	in vivo measures of neurotransmitters including glutamate and gamma-Aminobutyric acid magnetic resonance spectroscopy	3 years