Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION (Dyslexie REMED)

Dyslexia is first described as a phonological deficit. Several studies report a neurovisual deficit in dyslexics. Some dyslexics have a visual deficit without phonological impairment, others have a pure phonological deficit, and still others have both types of deficits. From this observation the idea emerged to propose specific remediation protocols for people with visual impairments and to assess their effects on reading. At the theoretical level, if visual stimulation is able to improve reading performance, it is the demonstration of the existence of visual origin of dyslexia. At the clinical level, such a result not only opens the prospect of a different and more adapted rehabilitation for these types of dyslexia, but also the prospect, if the visual deficits are pre-existing to the learning of reading, to use them for early diagnosis and management.

Study Overview

• Status: Recruiting
• Conditions: Dyslexia
• Intervention / Treatment: Behavioral: visual stimulation with I pad; Behavioral: visual stimulation with lamp

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laure PISELLA, Dr; Phone Number: +33 04 72 91 34 12; Email: laure.pisella@inserm.fr
• Study Contact Backup: Name: Audrey VIALATTE, Dr; Phone Number: +33 04 72 91 34 12; Email: audrey.vialatte@inserm.fr

Study Locations

• France
  • Rhone Alpes
    • Bron, Rhone Alpes, France, 69500
      • Recruiting
      • Centre de Recherche en Neurosciences de Lyon
      • Contact: Laure PISELLA, Dr; Phone Number: +33 04 72 91 34 12; Email: laure.pisella@inserm.fr
      • Contact: Audrey VIALATTE, Dr; Phone Number: +33 04 72 91 34 12; Email: audrey.vialatte@inserm.fr
      • Principal Investigator: Laure PISELLA, Dr

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Male or female
• Aged 8 to 12
• Diagnosed dyslexics
• Normal or corrected to normal vision
• Legal guardians of children subjects providing their free, informed and written consent to participate in the study; With the child also giving orally his consent to participate.

Exclusion Criteria:

• other neurodevelopmental problem
• strabismus, amblyopia

For the glasses (group 2) : epileptic child are excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: remediation group 1; dyslexic children	Behavioral: visual stimulation with I pad; At the beginning of the study, for baseline condition, children will do 4 tests (visuo-spatial perception test, visual attention span, visual research, phonology tests). In the first group of the study, the children will do visual research exercises on I pad 10 minutes per day during one month = remediation. They will also do 4 reading aloud tests, once a month, for 3 months. The remediation exercises will be realized during the first, second or third month.
Experimental: remediation group 2; dyslexic children	Behavioral: visual stimulation with lamp; At the beginning of the study, for baseline condition, children will do the 4 tests like group 1. In the second group of the study, the children will do reading aloud tests, with lamp adjusted with different parameters = remediation (passive visual stimulation of a specific frequency believed to promote visual processing of written symbols).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reading performance	change in reading time	for arm 1: at baseline at 1 month at 2 month at 3 month For arm 2: 4 times in the same day, 4 consecutive reading sessions with a break in-between of minimum 5 minutes
reading performance	change in number of errors	for arm 1: at baseline at 1 month at 2 month at 3 month For arm 2: 4 times in the same day, 4 consecutive reading sessions with a break in-between of minimum 5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
score of Elementary Visuo-Spatial Perception test	comparisons of score of (lengths, sizes, angles and relative positions within and between objects). Minimum score = 36 and maximum (better) score = 72	one time at baseline
visual attention span	number of letters identified in a single ocular fixation (200 ms)	one time at baseline
Visual search time	average visual search time of symbols versus colored objects	one time at baseline
performance score on the phonology tests (EVALéo 6-15 = Evaluation of written language and oral language 6-15 years)	metaphonology = removal of phonemes. Minimum score = 0 and maximum (better) score = 20	one time at baseline

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Estimated): February 17, 2025
• Study Completion (Estimated): February 17, 2025

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Dyslexia; Remediation; Visual attention span; Visual search
• 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: 69HCL21_0736

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