NCT05514457

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 17, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

1.3 years

First QC Date

August 5, 2022

Last Update Submit

September 24, 2024

Conditions

Keywords

DyslexiaRemediationVisual attention spanVisual search

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • score of Elementary Visuo-Spatial Perception test

    one time at baseline

  • visual attention span

    one time at baseline

  • Visual search time

    one time at baseline

  • performance score on the phonology tests (EVALéo 6-15 = Evaluation of written language and oral language 6-15 years)

    one time at baseline

Study Arms (2)

remediation group 1

EXPERIMENTAL

dyslexic children

Behavioral: visual stimulation with I pad

remediation group 2

EXPERIMENTAL

dyslexic children

Behavioral: visual stimulation with lamp

Interventions

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.

remediation group 1

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).

remediation group 2

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • other neurodevelopmental problem
  • strabismus, amblyopia
  • For the glasses (group 2) : epileptic child are excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche en Neurosciences de Lyon

Bron, Auvergne-Rhône-Alpes, 69500, France

Location

MeSH Terms

Conditions

Dyslexia

Interventions

Photic StimulationProtein-Arginine DeiminasesLight

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative TechniquesHydrolasesEnzymesEnzymes and CoenzymesElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaOptical PhenomenaRadiationRadiation, Nonionizing

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2022

First Posted

August 24, 2022

Study Start

November 17, 2022

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations