Visual Attention Span Mobilisation for Dyslexia

Not Applicable

Completed

• Conditions: Dyslexia; Visual Attention Span Deficit
• Interventions: Device: MAEVAD; Device: DeCaLigne

• Registration Number: NCT05201235
• Lead Sponsor: Humans Matter

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.

Study Timeline

• Study First Submitted: 2022-01-07
• Study Start: 2022-01-17
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-01-21
• Primary Completion: 2023-07-05
• Study Completion: 2023-07-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MAEVAD - DeCaLigne	MAEVAD	The experimental group will first receive MAEVAD then the control therapy
DeCaLigne - MAEVAD	DeCaLigne	The control group will first receive the control therapy then MAEVAD

Primary Outcome Measures

Name	Time	Method
Reading speed	26 weeks to baseline	Measure of reding time from texts of 122 to 152 words

Secondary Outcome Measures

Name	Time	Method
Orthographic skills	26 weeks to baseline	Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)
Reading skills	26 weeks to baseline	Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)
VA Span	26 weeks to baseline	Evadys test : EVADYS(c) provides a reliable diagnosis of visual-attention span disorder. The software includes three versions of the global and partial report tests, each adapted to a given age group.
Phonologic skills	26 weeks to baseline	Evalec(c) test : The child will have to delete, orally, the first phoneme of the pseudowords presented on the screen.; 12 pseudowords with a consonant-vowel-consonant structure and 12 with a consonant-consonant-vowel structure are presented one by one on the screen.
Mathematical skills	18 weeks to baseline	DeCaLigne(c) and Examath(c): The child will have to find the position of a number on a numerical line and answer mental calculation.

Trial Locations

Locations (55)

BERARD Marine; 🇫🇷 Albertville, France

CLAVIER-MARCOUX Laetitia; 🇫🇷 Antibes, France

MINIAC-FOURNIER Stéphanie; 🇫🇷 Chateau-gontier, France

CASTERES Catherine; 🇫🇷 Digoin, France

BERNARD-DENIS Fabienne; 🇫🇷 Le Havre, France

VOLUET FROMENT Adeline; 🇫🇷 Le Chesnay, France

VERLOT-MORY Ludivine; 🇫🇷 Meuilley, France

NADAUD Stéphanie; 🇫🇷 Saint-Nom-la-Bretêche, France

SHAW PERRIN Anne-Sophie; 🇫🇷 Irigny, France

RAYNAUD LEGROS Caroline; 🇫🇷 Sainte-anne, France

CARCEY-CADET Elise; 🇫🇷 Albertville, France

KOUASSI-PUJOL Marie; 🇫🇷 Albi, France

BIRAN Sandrine; 🇫🇷 Bordes, France

MARTINELLI Karen; 🇫🇷 Ajaccio, France

BOCCOGNANI Jordane; 🇫🇷 Argences-en-Aubrac, France

CHAUVET Clémence; 🇫🇷 Arles, France

SCHMITT Véronique; 🇫🇷 Biganos, France

CRABÉ Marion; 🇫🇷 Billère, France

CHABERT Claire; 🇫🇷 Bagnères-de-Bigorre, France

VALLERY Théoline; 🇫🇷 Brest, France

LADOUL Marine; 🇫🇷 Brive-la-Gaillarde, France

COURANT Sabrina; 🇫🇷 Cabasse, France

CONTESTI Véronique; 🇫🇷 Champagne-au-Mont-d'Or, France

PASQUIER Amélie; 🇫🇷 Fay de Bretagne, France

LEGENDRE Laure; 🇫🇷 Fontenay-sous-Bois, France

BLANC Emilie; 🇫🇷 Givors, France

FORTIER Anne; 🇫🇷 Garches, France

KRAYEM Mona; 🇫🇷 Guichainville, France

RIZK Joumana; 🇫🇷 Guichainville, France

DE MUYNCK Solène; 🇫🇷 Lamballe, France

CADALEN Hélène; 🇫🇷 Lanmeur, France

CALAIS Cécile; 🇫🇷 Liancourt, France

TERRASSON Cécile; 🇫🇷 Le Touquet-Paris-Plage, France

Britt; 🇫🇷 Lux, France

JORDANIS Mélanie; 🇫🇷 Marignier, France

GOBÉ Valérie; 🇫🇷 Machecoul, France

MAZERAN Anne-Cécile; 🇫🇷 Miribel, France

EMERIAU Mathilde; 🇫🇷 Nantes, France

KIS Nathalie; 🇫🇷 Montigny-le-Bretonneux, France

LHUILLIER Françoise; 🇫🇷 Neufchateau, France

BERTHELOT Florence; 🇫🇷 Plerin, France

BRESSON Raphaëlle; 🇫🇷 Plaisir, France

LECLERC LE COADOU Rozenn; 🇫🇷 Saint Lô, France

LEJOSNE Julie; 🇫🇷 Paimpol, France

CAMUS-BRUNEAU Anne; 🇫🇷 Reze, France

VIERLING Pauline; 🇫🇷 Saint-leu, France

ZIMMERMAN Amélie; 🇫🇷 Remoulins, France

BERTHOLOM Anne-Marine; 🇫🇷 Ploudalmézeau, France

KOCHEL Jeanne-Marie; 🇫🇷 Saint Germain En Laye, France

REVERSE Christelle; 🇫🇷 Saint-peray, France

DESCENDRE Myriam; 🇫🇷 Saint Quentin, France

AÏT LEMKADEM Mimouna; 🇫🇷 Sartrouville, France

FRITSCH Colombine; 🇫🇷 Schiltigheim, France

CARRIQUE Pascale; 🇫🇷 Tourrettes, France

KALCK Christine; 🇫🇷 Vendenheim, France