Neurofunctional Correlates of the Behavioral Modifications Associated With Tachidino in Children With Developmental Dyslexia (TACHIDINO)

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 Overview

• Status: Recruiting
• Conditions: Dyslexia, Developmental
• Intervention / Treatment: Behavioral: TACHIDINO

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Mascheretti, PhD; Phone Number: +39031877924; Email: sara.mascheretti@lanostrafamiglia.it

Study Locations

• Italy
  • LC
    • Bosisio Parini, LC, Italy, 23842
      • Recruiting
      • Scientific Institute IRCCS Eugenio Medea
      • Contact: Sara Mascheretti, PhD; Phone Number: +39031877924; Email: sara.mascheretti@lanostrafamiglia.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Reading skills (both accuracy and speed) below -2.00 standard deviation

Exclusion Criteria:

• No ADHD
• No contraindications to magnetic resonance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TACHIDINO	Behavioral: TACHIDINO; 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).
No Intervention: WAITING LIST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain activation as assessed by fMRI	BOLD signal in regions of interest (ROIs) underlying reading network	baseline
Brain activation as assessed by fMRI	BOLD signal in regions of interest (ROIs) underlying reading network	before the intervention
Brain activation as assessed by fMRI	BOLD signal in regions of interest (ROIs) underlying reading network	immediately after the intervention

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Dyslexia
• Other Study ID Numbers: 877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No