Clinical trial NCT05201235: Visual Attention Span Mobilisation for Dyslexia
Official title: Maevad - Mobilisation Active de l'Empan Visuo-Attentionel Pour la Dyslexie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslexia
Visual Attention Span Deficit
Keywords: MAEVAD
MAEVA
Reading
Remediation
Visual attention span
Lead sponsor: Humans Matter
Sponsor class: INDUSTRY
First posted: 2022-01-21
Enrollment: 74
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reading speed
timeFrame: 10 weeks to baseline
measure: Reading speed
timeFrame: 18 weeks to baseline
measure: Reading speed
timeFrame: 26 weeks to baseline
Secondary outcomes:
measure: Reading skills
timeFrame: 10 weeks to baseline
measure: Reading skills
timeFrame: 18 weeks to baseline
measure: Reading skills
timeFrame: 26 weeks to baseline
measure: Orthographic skills
timeFrame: 10 weeks to baseline
measure: Orthographic skills
timeFrame: 18 weeks to baseline
measure: Orthographic skills
timeFrame: 26 weeks to baseline
measure: VA Span
timeFrame: 10 weeks to baseline
measure: VA Span
timeFrame: 18 weeks to baseline
measure: VA Span
timeFrame: 26 weeks to baseline
measure: Phonologic skills
timeFrame: 10 weeks to baseline
measure: Phonologic skills
timeFrame: 18 weeks to baseline
measure: Phonologic skills
timeFrame: 26 weeks to baseline
measure: Mathematical skills
timeFrame: 10 weeks to baseline
measure: Mathematical skills
timeFrame: 18 weeks to baseline
Other outcomes:
Locations:
city: Ajaccio
country: France
facility: MARTINELLI Karen
city: Albertville
country: France
facility: BERARD Marine
city: Albertville
country: France
facility: CARCEY-CADET Elise
city: Albi
country: France
facility: KOUASSI-PUJOL Marie
city: Antibes
country: France
facility: CLAVIER-MARCOUX Laetitia
city: Argences-en-Aubrac
country: France
facility: BOCCOGNANI Jordane
city: Arles
country: France
facility: CHAUVET Clémence
city: Bagnères-de-Bigorre
country: France
facility: CHABERT Claire
city: Biganos
country: France
facility: SCHMITT Véronique
city: Billère
country: France
facility: CRABÉ Marion
city: Bordes
country: France
facility: BIRAN Sandrine
city: Brest
country: France
facility: VALLERY Théoline
city: Brive-la-Gaillarde
country: France
facility: LADOUL Marine
city: Cabasse
country: France
facility: COURANT Sabrina
city: Champagne-au-Mont-d'Or
country: France
facility: CONTESTI Véronique
city: Chateau-gontier
country: France
facility: MINIAC-FOURNIER Stéphanie
city: Digoin
country: France
facility: CASTERES Catherine
city: Fay de Bretagne
country: France
facility: PASQUIER Amélie
city: Fontenay-sous-Bois
country: France
facility: LEGENDRE Laure
city: Garches
country: France
facility: FORTIER Anne
city: Givors
country: France
facility: BLANC Emilie
city: Guichainville
country: France
facility: KRAYEM Mona
city: Guichainville
country: France
facility: RIZK Joumana
city: Irigny
country: France
facility: SHAW PERRIN Anne-Sophie
city: Lamballe
country: France
facility: DE MUYNCK Solène
city: Lanmeur
country: France
facility: CADALEN Hélène
city: Le Chesnay
country: France
facility: VOLUET FROMENT Adeline
city: Le Havre
country: France
facility: BERNARD-DENIS Fabienne
city: Le Touquet-Paris-Plage
country: France
facility: TERRASSON Cécile
city: Liancourt
country: France
facility: CALAIS Cécile
city: Lux
country: France
facility: Britt
city: Machecoul
country: France
facility: GOBÉ Valérie
city: Marignier
country: France
facility: JORDANIS Mélanie
city: Meuilley
country: France
facility: VERLOT-MORY Ludivine
city: Miribel
country: France
facility: MAZERAN Anne-Cécile
city: Montigny-le-Bretonneux
country: France
facility: KIS Nathalie
city: Nantes
country: France
facility: EMERIAU Mathilde
city: Neufchateau
country: France
facility: LHUILLIER Françoise
city: Paimpol
country: France
facility: LEJOSNE Julie
city: Plaisir
country: France
facility: BRESSON Raphaëlle
city: Plerin
country: France
facility: BERTHELOT Florence
city: Ploudalmézeau
country: France
facility: BERTHOLOM Anne-Marine
city: Remoulins
country: France
facility: ZIMMERMAN Amélie
city: Reze
country: France
facility: CAMUS-BRUNEAU Anne
city: Saint Germain En Laye
country: France
facility: KOCHEL Jeanne-Marie
city: Saint Lô
country: France
facility: LECLERC LE COADOU Rozenn
city: Saint Quentin
country: France
facility: DESCENDRE Myriam
city: Saint-leu
country: France
facility: VIERLING Pauline
city: Saint-Nom-la-Bretêche
country: France
facility: NADAUD Stéphanie
city: Saint-peray
country: France
facility: REVERSE Christelle
city: Sainte-anne
country: France
facility: RAYNAUD LEGROS Caroline
city: Sartrouville
country: France
facility: AÏT LEMKADEM Mimouna
city: Schiltigheim
country: France
facility: FRITSCH Colombine
city: Tourrettes
country: France
facility: CARRIQUE Pascale
city: Vendenheim
country: France
facility: KALCK Christine
Study officials:
affiliation: Humans Matter
name: Mélodie FOUILLEN, PhD
role: STUDY_CHAIR
References: