Dyslexia, DevelopmentalTACHIDINONCT05373576
Neurofunctional Correlates of the Behavioral Modifications Associated With Tachidino in Children With Developmental Dyslexia
A study testing TACHIDINO in people with Dyslexia, Developmental, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
Developmental dyslexia (DD) is the most common learning disorder. Multiple cognitive and sensory domains contribute to the etiology of DD and develop before reading acquisition. Atypical brain functional responses and structural features have been found in the reading developing circuitry. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Dyslexia, Developmental
- What is being tested?
- TACHIDINO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2022to 31 Dec 2023
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Reading skills (both accuracy and speed) below -2.00 standard deviation
Who cannot join
- No ADHD
- No contraindications to magnetic resonance
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Scientific Institute IRCCS Eugenio Medea
Bosisio Parini, LC, 23842
Sara Mascheretti, PhD, +39031877924, sara.mascheretti@lanostrafamiglia.it
About this study
Developmental dyslexia (DD) is the most common learning disorder. Multiple cognitive and sensory domains contribute to the etiology of DD and develop before reading acquisition. Atypical brain functional responses and structural features have been found in the reading developing circuitry. Treatments addressing visual-spatial attention and motion perception (Visual Attention Training; VAT) are among the most effective interventions in Italian children with DD. The VAT seems to improve the efficiency of the visual attention system and the magnocellular (M) pathway which is crucial for learning to read. Evidence for impaired M function in subjects with DD in the visual striate and extra-striate cortex have been reported. How these treatments affect the brain functionality is still not clear. Since DD has a neurobiological basis, it is important to deeply investigate atypical functional responses and structural features in reading-related areas, and to understand how treatments operate at the neuronal level. A growing number of studies investigates structural and functional measures in neurodevelopmental disorders by using high-resolution MRI at high field (3T and 7T). Similarly, several studies examine the effects of different types of reading training upon brain activity. Better understanding of the relationship between structural/functional abnormalities and DD could disentangle the causes of reading difficulties and helps in developing effective treatments.
The significance of this study is twofold: 1) NEURAL CORRELATES OF TREATMENT: The investigators expect TACHIDINO to specifically affect the underlying neurophysiological functioning which influences reading skills in children with DD; 2) BRAIN SIGNATURES: As integrated multi-domain data (behavioral and brain imaging) are complementary to each other, they could enhance the possibility to find unique treatment/brain functioning combinations to evaluate the effectiveness of intervention and to predict the treatment response.
- Conditions
- Dyslexia, Developmental
- Being tested
- TACHIDINO
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACHIDINOBehavioural
TACHIDINO is based on two principles a) selective stimulation of a cerebral hemisphere and specific reading strategies, and b) the training of selective visuospatial attention, as well as the perception of rapid movement and the visual characteristics of words even in the presence of so-called visual crowding or "crowding", an automatic effect of our perceptual system that leads to "obfuscation" of the visual areas surrounding the object to be analyzed, to make its vision clearer (as suggested by the "Magnocellular theory" of dyslexia; Stein et al., 2019).
| Study group | Role | What they receive |
|---|---|---|
| TACHIDINO | Experimental | Not described Receives: Behavioral: TACHIDINO |
| WAITING LIST | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activation as assessed by fMRI
BOLD signal in regions of interest (ROIs) underlying reading network
Measured: baseline
Brain activation as assessed by fMRI
BOLD signal in regions of interest (ROIs) underlying reading network
Measured: before the intervention
Brain activation as assessed by fMRI
BOLD signal in regions of interest (ROIs) underlying reading network
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start2 Jan 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyslexia, DevelopmentalStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373576
- Sponsor's protocol ID
- 877
- Acronym
- TACHIDINO
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 20 May 2022
- Results posted
- 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 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofunctional Correlates of the Behavioral Modifications Associated With Tachidino in Children With Developmental Dyslexia
- ClinicalTrials.gov ID
- NCT05373576
- Acronym / sponsor ID
- TACHIDINO / 877
- Conditions
- Dyslexia, Developmental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 May 2022 (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 (DD) is the most common learning disorder. Multiple cognitive and sensory domains contribute to the etiology of DD and develop before reading acquisition. Atypical brain functional responses and structural features have been found in the reading developing circuitry. Treatments addressing visual-spatial attention and motion perception (Visual Attention Training; VAT) are among the most effective interventions in Italian children with DD. The VAT seems to improve the efficiency of the visual attention system and the magnocellular (M) pathway which is crucial for learning to read. Evidence for impaired M function in subjects with DD in the visual striate and extra-striate cortex have been reported. How these treatments affect the brain functionality is still not clear. Since DD has a neurobiological basis, it is important to deeply investigate atypical functional responses and structural features in reading-related areas, and to understand how treatments operate at the neuronal level. A growing number of studies investigates structural and functional measures in neurodevelopmental disorders by using high-resolution MRI at high field (3T and 7T). Similarly, several studies examine the effects of different types of reading training upon brain activity. Better understanding of the relationship between structural/functional abnormalities and DD could disentangle the causes of reading difficulties and helps in developing effective treatments.
The significance of this study is twofold: 1) NEURAL CORRELATES OF TREATMENT: The investigators expect TACHIDINO to specifically affect the underlying neurophysiological functioning which influences reading skills in children with DD; 2) BRAIN SIGNATURES: As integrated multi-domain data (behavioral and brain imaging) are complementary to each other, they could enhance the possibility to find unique treatment/brain functioning combinations to evaluate the effectiveness of intervention and to predict the treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACHIDINO | Experimental | Behavioral: TACHIDINO |
| WAITING LIST | No intervention | – |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Reading skills (both accuracy and speed) below -2.00 standard deviation
Key exclusion criteria (2 listed)
- No ADHD
- No contraindications to magnetic resonance
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 |
|---|---|---|
| TACHIDINOTACHIDINO is based on two principles a) selective stimulation of a cerebral hemisphere and specific reading strategies, and b) the training of selective visuospatial attention, as well as the perception of rapid movement and the visual characteristics of words even in the presence of so-called visual crowding or "crowding", an automatic effect of our perceptual system that leads to "obfuscation" of the visual areas surrounding the object to be analyzed, to make its vision clearer (as suggested by the "Magnocellular theory" of dyslexia; Stein et al., 2019). | Behavioural | TACHIDINO |
Primary outcome
Brain activation as assessed by fMRI
Time frame: baseline
BOLD signal in regions of interest (ROIs) underlying reading network
Brain activation as assessed by fMRI
Time frame: before the intervention
BOLD signal in regions of interest (ROIs) underlying reading network
Brain activation as assessed by fMRI
Time frame: immediately after the intervention
BOLD signal in regions of interest (ROIs) underlying reading network
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- 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 TACHIDINO in people with Dyslexia, Developmental, 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 1 inclusion and 2 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 20 May 2022. 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, PhD (+39031877924, sara.mascheretti@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activation as assessed by fMRI (time frame: baseline). The study lists 3 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 20 May 2022.