Reading DisorderGedysNCT06186882
Gene x Environment Interplay in Developmental Dyslexia Treatment: A Round-trip Translation Between Humans and Animal
A study testing Action Video-Game in people with Reading Disorder, run by IRCCS Eugenio Medea at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Reading Disorder
- What is being tested?
- Action Video-Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 5-years old pre-readers,
- normal intelligence quotient,
- no main counter indications for magnetic resonance acquisition,
- no previous diagnosis of any neurodevelopmental disorders.
Who cannot join
- intelligence quotient below the average range,
- presence of counter indications for magnetic resonance acquisition,
- previous diagnosis of any neurodevelopmental disorders.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Scientific Institute IRCCS E Medea
Bosisio Parini, LC, 23842
Sara Mascheretti, 031877985, sara.mascheretti@lanostrafamiglia.it
About this study
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
- Being tested
- Action Video-Game
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Video-GameBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ENVIRONMENTAL STIMULATION | Experimental | Not described Receives: Behavioral: Action Video-Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term memory
Short-term memory - assessed by the Single Digit Forward Span, Single Digit Backward Span. Measures obtained: Z scores age-corrected.
Measured: 3 years
Phonological awareness
Phonological awareness - assessed by the nonword repetition test. Measures obtained: Z scores age-corrected.
Measured: 3 years
Rapid automatized naming
Rapid automatized naming - assessed by the RAN test. Measures obtained: Z scores age-corrected.
Measured: 3 years
Reading skills
Reading skills - assessed by single unrelated words and pseudo-words reading tests. Measures obtained: Z scores age-corrected.
Measured: 3 years
Visual attention
Visual attention - assessed by a computer-based visual attention task
Measured: 3 years
Visual motion processing
Visual motion processing - assessed by Coherent dot motion task
Measured: 3 years
measurement of neurotransmitters
in vivo measures of neurotransmitters including glutamate and gamma-Aminobutyric acid magnetic resonance spectroscopy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start30 Apr 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reading DisorderStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli studi di Bergamo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186882
- Sponsor's protocol ID
- GR-2021-12375102
- Acronym
- Gedys
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene x Environment Interplay in Developmental Dyslexia Treatment: A Round-trip Translation Between Humans and Animal
- ClinicalTrials.gov ID
- NCT06186882
- Acronym / sponsor ID
- Gedys / GR-2021-12375102
- Conditions
- Reading Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- Università degli studi di Bergamo
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENVIRONMENTAL STIMULATION | Experimental | Behavioral: Action Video-Game |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 5-years old pre-readers,
- normal intelligence quotient,
- no main counter indications for magnetic resonance acquisition,
- no previous diagnosis of any neurodevelopmental disorders.
Key exclusion criteria (3 listed)
- intelligence quotient below the average range,
- presence of counter indications for magnetic resonance acquisition,
- previous diagnosis of any neurodevelopmental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Video-GameThanks 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. | Behavioural | ENVIRONMENTAL STIMULATION |
Primary outcome
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.
Phonological awareness
Time frame: 3 years
Phonological awareness - assessed by the nonword repetition test. Measures obtained: Z scores age-corrected.
Rapid automatized naming
Time frame: 3 years
Rapid automatized naming - assessed by the RAN test. Measures obtained: Z scores age-corrected.
Reading skills
Time frame: 3 years
Reading skills - assessed by single unrelated words and pseudo-words reading tests. Measures obtained: Z scores age-corrected.
Visual attention
Time frame: 3 years
Visual attention - assessed by a computer-based visual attention task
Visual motion processing
Time frame: 3 years
Visual motion processing - assessed by Coherent dot motion task
measurement of neurotransmitters
Time frame: 3 years
in vivo measures of neurotransmitters including glutamate and gamma-Aminobutyric acid magnetic resonance spectroscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Video-Game in people with Reading Disorder, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Mascheretti (031877895, sara.mascheretti@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term memory (time frame: 3 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.