Neurofunctional Correlates of the Behavioral Modifications Associated With Tachidino in Children With Developmental Dyslexia (TACHIDINO)
Primary Purpose
Dyslexia, Developmental
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
TACHIDINO
Sponsored by
About this trial
This is an interventional treatment trial for Dyslexia, Developmental
Eligibility Criteria
Inclusion Criteria:
- Reading skills (both accuracy and speed) below -2.00 standard deviation
Exclusion Criteria:
- No ADHD
- No contraindications to magnetic resonance
Sites / Locations
- Scientific Institute IRCCS Eugenio MedeaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TACHIDINO
WAITING LIST
Arm Description
Outcomes
Primary Outcome Measures
Brain activation as assessed by fMRI
BOLD signal in regions of interest (ROIs) underlying reading network
Brain activation as assessed by fMRI
BOLD signal in regions of interest (ROIs) underlying reading network
Brain activation as assessed by fMRI
BOLD signal in regions of interest (ROIs) underlying reading network
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05373576
Brief Title
Neurofunctional Correlates of the Behavioral Modifications Associated With Tachidino in Children With Developmental Dyslexia
Acronym
TACHIDINO
Official Title
Neurofunctional Correlates of the Behavioral Modifications Associated With Tachidino in Children With Developmental Dyslexia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Eugenio Medea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslexia, Developmental
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TACHIDINO
Arm Type
Experimental
Arm Title
WAITING LIST
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
TACHIDINO
Intervention Description
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).
Primary Outcome Measure Information:
Title
Brain activation as assessed by fMRI
Description
BOLD signal in regions of interest (ROIs) underlying reading network
Time Frame
baseline
Title
Brain activation as assessed by fMRI
Description
BOLD signal in regions of interest (ROIs) underlying reading network
Time Frame
before the intervention
Title
Brain activation as assessed by fMRI
Description
BOLD signal in regions of interest (ROIs) underlying reading network
Time Frame
immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Reading skills (both accuracy and speed) below -2.00 standard deviation
Exclusion Criteria:
No ADHD
No contraindications to magnetic resonance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Mascheretti, PhD
Phone
+39031877924
Email
sara.mascheretti@lanostrafamiglia.it
Facility Information:
Facility Name
Scientific Institute IRCCS Eugenio Medea
City
Bosisio Parini
State/Province
LC
ZIP/Postal Code
23842
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Mascheretti, PhD
Phone
+39031877924
Email
sara.mascheretti@lanostrafamiglia.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neurofunctional Correlates of the Behavioral Modifications Associated With Tachidino in Children With Developmental Dyslexia
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