DyslexiaNCT05201235
Visual Attention Span Mobilisation for Dyslexia
A study testing MAEVAD and DeCaLigne in people with Dyslexia and Visual Attention Span Deficit, run by Humans Matter at 55 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Dyslexia, Visual Attention Span Deficit
- What is being tested?
- MAEVAD and DeCaLigne
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 55 sitesFrance
- Study dates
- 17 Jan 2022to 5 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
55 sites in 1 country.
55 sites in 1 country
France55 sites
MARTINELLI Karen
Ajaccio, 20000
BERARD Marine
Albertville, 73200
CARCEY-CADET Elise
Albertville, 73200
KOUASSI-PUJOL Marie
Albi, 81000
CLAVIER-MARCOUX Laetitia
Antibes, 06600
BOCCOGNANI Jordane
Argences en Aubrac, 12420
CHAUVET Clémence
Arles, 13200
CHABERT Claire
Bagnères-de-Bigorre, 65200
SCHMITT Véronique
Biganos, 33380
CRABÉ Marion
Billère, 64140
BIRAN Sandrine
Bordes, 64510
VALLERY Théoline
Brest, 29200
LADOUL Marine
Brive-la-Gaillarde, 19100
COURANT Sabrina
Cabasse, 83340
CONTESTI Véronique
Champagne-au-Mont-d'Or, 69410
MINIAC-FOURNIER Stéphanie
Château-Gontier, 53200
CASTERES Catherine
Digoin, 71160
PASQUIER Amélie
Fay-de-Bretagne, 44130
LEGENDRE Laure
Fontenay-sous-Bois, 94120
FORTIER Anne
Garches, 92380
BLANC Emilie
Givors, 69700
KRAYEM Mona
Guichainville, 27930
RIZK Joumana
Guichainville, 27930
SHAW PERRIN Anne-Sophie
Irigny, 69100
DE MUYNCK Solène
Lamballe, 22400
CADALEN Hélène
Lanmeur, 29620
VOLUET FROMENT Adeline
Le Chesnay, 78150
BERNARD-DENIS Fabienne
Le Havre, 76000
TERRASSON Cécile
Le Touquet-Paris-Plage, 62520
CALAIS Cécile
Liancourt, 60140
Britt
Lux, 71100
GOBÉ Valérie
Machecoul, 44270
JORDANIS Mélanie
Marignier, 74970
VERLOT-MORY Ludivine
Meuilley, 21700
MAZERAN Anne-Cécile
Miribel, 01700
KIS Nathalie
Montigny-le-Bretonneux, 78180
EMERIAU Mathilde
Nantes, 44000
LHUILLIER Françoise
Neufchâteau, 88300
LEJOSNE Julie
Paimpol, 22500
BRESSON Raphaëlle
Plaisir, 78370
BERTHELOT Florence
Plérin, 22190
BERTHOLOM Anne-Marine
Ploudalmézeau, 29830
ZIMMERMAN Amélie
Remoulins, 30210
CAMUS-BRUNEAU Anne
Rezé, 44400
KOCHEL Jeanne-Marie
Saint-Germain-en-Laye, 78100
VIERLING Pauline
Saint-Leu, 97416
LECLERC LE COADOU Rozenn
Saint-Lô, 50 000
NADAUD Stéphanie
Saint-Nom-la-Bretêche, 78860
REVERSE Christelle
Saint-Péray, 07130
DESCENDRE Myriam
Saint-Quentin, 02100
RAYNAUD LEGROS Caroline
Sainte-Anne, 97180
AÏT LEMKADEM Mimouna
Sartrouville, 78500
FRITSCH Colombine
Schiltigheim, 67300
CARRIQUE Pascale
Tourrettes, 83440
KALCK Christine
Vendenheim, 67550
About this study
Official title: Maevad - Mobilisation Active de l'Empan Visuo-Attentionel Pour la Dyslexie
The aim of the study is to evaluate the efficiency of the medical device MAEVAD in improving the reading skills of children with dyslexia.
Read the 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.
- Conditions
- Dyslexia, Visual Attention Span Deficit
- Being tested
- MAEVAD, DeCaLigne
- Keywords
- MAEVAD, MAEVA, Reading, Remediation, Visual attention span
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAEVADDevice
MAEVAD is a training device which aims to improve VA span as a prerequisite for learning to read. By increasing the number of distinct visual elements that can be processed simultaneously during fixation, MAEVAD is intended to improve the reading (accuracy and fluency) and spelling (lexical) performance of dyslexics who have a VA span deficit. MAEVAD is designed to be used in total autonomy by dyslexic children with a VA span disorder. The therapy takes place over 6 weeks with 5 sessions of 15 minutes per week. In order to improve compliance, the therapy has been integrated into "le Royaume d'Adelia", a serious game where the child will be able to collect materials at the end of each session that will allow him to create objects to customise a character.
DeCaLigneDevice
DéCaLigne is an intervention programme for the discovery of calculation with the number line. The objectives are to improve numerical representations in the form of a number line and to improve addition and subtraction skills. The overall principle is to move numbers or calculation results on a number line. This training does not stimulate VA span or the phonological dimensions involved in reading. This therapy is being adapted to be used in total autonomy at home and to correspond to the MAEVAD therapy in duration (5 sessions of 15 minutes per week for 6 weeks). It has also been integrated into the "royaume d'Adelia" in order to control the motivational effect of the serious game.
| Study group | Role | What they receive |
|---|---|---|
| MAEVAD - DeCaLigne | Experimental | The experimental group will first receive MAEVAD then the control therapy Receives: Device: MAEVAD |
| DeCaLigne - MAEVAD | Placebo comparator | The control group will first receive the control therapy then MAEVAD Receives: Device: DeCaLigne |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading speed
Measure of reding time from texts of 122 to 152 words
Measured: 10 weeks to baseline
Reading speed
Measure of reding time from texts of 122 to 152 words
Measured: 18 weeks to baseline
Reading speed
Measure of reding time from texts of 122 to 152 words
Measured: 26 weeks to baseline
Secondary outcomes (14)
Reading skills
Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)
Measured: 10 weeks to baseline
Reading skills
Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)
Measured: 18 weeks to baseline
Reading skills
Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)
Measured: 26 weeks to baseline
Orthographic skills
Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)
Measured: 10 weeks to baseline
Orthographic skills
Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)
Measured: 18 weeks to baseline
Orthographic skills
Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)
Measured: 26 weeks to baseline
VA Span
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.
Measured: 10 weeks to baseline
VA Span
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.
Measured: 18 weeks to baseline
VA Span
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.
Measured: 26 weeks to baseline
Phonologic skills
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.
Measured: 10 weeks to baseline
Phonologic skills
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.
Measured: 18 weeks to baseline
Phonologic skills
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.
Measured: 26 weeks to baseline
Mathematical skills
DeCaLigne(c) and Examath(c): The child will have to find the position of a number on a numerical line and answer mental calculation.
Measured: 10 weeks to baseline
Mathematical skills
DeCaLigne(c) and Examath(c): The child will have to find the position of a number on a numerical line and answer mental calculation.
Measured: 18 weeks to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start17 Jan 2022
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humans Matter
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mélodie FOUILLEN, PhD, Study chair, Humans Matter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201235
- Sponsor's protocol ID
- 2021-A01457-34
- Status last verified
- Feb 2024
- First submitted
- 7 Jan 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maevad - Mobilisation Active de l'Empan Visuo-Attentionel Pour la Dyslexie
- ClinicalTrials.gov ID
- NCT05201235
- Acronym / sponsor ID
- 2021-A01457-34
- Conditions
- Dyslexia, Visual Attention Span Deficit
- Keywords
- MAEVAD, MAEVA, Reading, Remediation, Visual attention span
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Humans MatterIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MAEVAD - DeCaLigne | Experimental | Device: MAEVADThe experimental group will first receive MAEVAD then the control therapy |
| DeCaLigne - MAEVAD | Placebo comparator | Device: DeCaLigneThe control group will first receive the control therapy then MAEVAD |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAEVADMAEVAD is a training device which aims to improve VA span as a prerequisite for learning to read. By increasing the number of distinct visual elements that can be processed simultaneously during fixation, MAEVAD is intended to improve the reading (accuracy and fluency) and spelling (lexical) performance of dyslexics who have a VA span deficit. MAEVAD is designed to be used in total autonomy by dyslexic children with a VA span disorder. The therapy takes place over 6 weeks with 5 sessions of 15 minutes per week. In order to improve compliance, the therapy has been integrated into "le Royaume d'Adelia", a serious game where the child will be able to collect materials at the end of each session that will allow him to create objects to customise a character. | Device | MAEVAD - DeCaLigne |
| DeCaLigneDéCaLigne is an intervention programme for the discovery of calculation with the number line. The objectives are to improve numerical representations in the form of a number line and to improve addition and subtraction skills. The overall principle is to move numbers or calculation results on a number line. This training does not stimulate VA span or the phonological dimensions involved in reading. This therapy is being adapted to be used in total autonomy at home and to correspond to the MAEVAD therapy in duration (5 sessions of 15 minutes per week for 6 weeks). It has also been integrated into the "royaume d'Adelia" in order to control the motivational effect of the serious game. | Device | DeCaLigne - MAEVAD |
Primary outcome
Reading speed
Time frame: 10 weeks to baseline
Measure of reding time from texts of 122 to 152 words
Reading speed
Time frame: 18 weeks to baseline
Measure of reding time from texts of 122 to 152 words
Reading speed
Time frame: 26 weeks to baseline
Measure of reding time from texts of 122 to 152 words
14 secondary outcomes
Reading skills
Time frame: 10 weeks to baseline
Reading skills
Time frame: 18 weeks to baseline
Reading skills
Time frame: 26 weeks to baseline
Orthographic skills
Time frame: 10 weeks to baseline
Orthographic skills
Time frame: 18 weeks to baseline
Orthographic skills
Time frame: 26 weeks to baseline
VA Span
Time frame: 10 weeks to baseline
VA Span
Time frame: 18 weeks to baseline
VA Span
Time frame: 26 weeks to baseline
Phonologic skills
Time frame: 10 weeks to baseline
Phonologic skills
Time frame: 18 weeks to baseline
Phonologic skills
Time frame: 26 weeks to baseline
Mathematical skills
Time frame: 10 weeks to baseline
Mathematical skills
Time frame: 18 weeks to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mélodie FOUILLEN, PhD study chair
Humans Matter
55 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAEVAD and DeCaLigne in people with Dyslexia and Visual Attention Span Deficit, run by Humans Matter at 55 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading speed (time frame: 10 weeks to baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.