Visual Attention Span Mobilisation for Dyslexia

Humans Matter

Status: Completed

Conditions: Visual Attention Span Deficit; Dyslexia

Treatments: Device: MAEVAD; Device: DeCaLigne

Study type: Interventional

Funder types: Industry

Identifiers

NCT05201235

2021-A01457-34

Details and patient eligibility

About

The aim of the study is to evaluate the efficiency of the medical device MAEVAD in improving the reading skills of children with dyslexia.

Full description

MAEVAD is a digital therapy specifically designed to improve the visual attention (VA) span of children with dyslexia. Dyslexia is characterized by a specific and significant impairment in reading and/or writing production and spelling. Some profiles of children with dyslexia show a deficit in VA span, characterized by a decrease in the number of distinct visual elements that can be processed simultaneously. VA span plays a critical role in the acquisition of reading skills and specific knowledge of word spelling. Brain regions involved in visual-attentional skills are under-activated in dyslexic children with VA deficits and can be reactivated following specific and intensive VA span training.

In this study 150 children with dyslexia will be randomized in tow groups. On the first group children will be trained first with MAEVAD then with a control training that does not stimulate the VA span. On contrary, on the second group children will first perform the control training and then MAEVAD.

For each intervention the sessions will lasts 15 minutes. 5 sessions are planned per weeks for 6 weeks.

Enrollment: 74 patients

Sex: All

Ages: 8 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• School children from CE2 to CM2, aged 8 to 11 years
• Dyslexic children with a VA span deficit (composite visual-attention span below the fifteenth percentile and a letter threshold above or equal to the twentieth percentile with the - - - Evadys(c) battery)
• Established diagnosis of Dyslexia
• Children whose parents/legal guardians have signed informed consent and agree to participate in the study
• Children whose first language is French or who have been educated in French since kindergarten
• Raven's Progressive Matrices score above the 20th percentile or a WISC IV or V Verbal Comprehension Index or WISC IV or V Perceptual/Fluid Reasoning Index above 85 or documented/objectifiable absence of intellectual deficit
• Child with access to a computer
• Normal or corrected vision and audition

Exclusion criteria

• Attention deficit hyperactivity disorder,dysphasia, dyspraxia, Autism Spectrum Disorder
• Neurological disorders
• Children who have missed 3 months or more of school in the current or previous year (excluding lockdown)
• Children not affiliated to a social security scheme

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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74 participants in 2 patient groups, including a placebo group

MAEVAD - DeCaLigne

Experimental group

Description:

The experimental group will first receive MAEVAD then the control therapy

Treatment:

Device: MAEVAD

DeCaLigne - MAEVAD

Placebo Comparator group

Description:

The control group will first receive the control therapy then MAEVAD

Treatment:

Device: DeCaLigne