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

Sponsor
IRCCS Eugenio Medea (Other)
Overall Status
Recruiting
CT.gov ID
NCT05373576
Collaborator
(none)
30
1
2
23.9
1.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: TACHIDINO
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Neurofunctional Correlates of the Behavioral Modifications Associated With Tachidino in Children With Developmental Dyslexia
Actual Study Start Date :
Jan 2, 2022
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Brain activation as assessed by fMRI [baseline]

    BOLD signal in regions of interest (ROIs) underlying reading network

  2. Brain activation as assessed by fMRI [before the intervention]

    BOLD signal in regions of interest (ROIs) underlying reading network

  3. Brain activation as assessed by fMRI [immediately after the intervention]

    BOLD signal in regions of interest (ROIs) underlying reading network

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Reading skills (both accuracy and speed) below -2.00 standard deviation
Exclusion Criteria:
  • No ADHD

  • No contraindications to magnetic resonance

Contacts and Locations

Locations

Site City State Country Postal Code
1 Scientific Institute IRCCS Eugenio Medea Bosisio Parini LC Italy 23842

Sponsors and Collaborators

  • IRCCS Eugenio Medea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
IRCCS Eugenio Medea
ClinicalTrials.gov Identifier:
NCT05373576
Other Study ID Numbers:
  • 877
First Posted:
May 13, 2022
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 20, 2022