- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07707700
Validating a Neurocognitive Remediation Model for Visual-Attentional Pathway in Chinese Developmental Dyslexia
Testing the Visual-Attentional Pathway in Chinese Developmental Dyslexia: A Randomized Controlled Trial to Validate a Neurocognitive Cascade Model of Remediation
Developmental dyslexia is a common and serious specific learning disability affecting up to one in eight children in Hong Kong, with profound consequences for academic success and personal well-being. For children learning to read the visually complex Chinese script, the challenge is particularly intense. A key research challenge is a long-standing "chicken-and-egg" debate: are weaknesses in the brain's fast-processing visual system (Magnocellular-Dorsal deficits) a cause of reading difficulties, or merely a consequence of limited reading practice? This uncertainty has constrained theoretical progress, creating a major barrier to developing effective, evidence-based support for struggling readers beyond traditional linguistic-based methods.
This project is designed to resolve this debate by directly testing if training a core visual-attentional skill can causally improve reading. The approach is built on investigator's strong pilot data, which established a novel "Neurocognitive Cascade Model": a framework suggesting that the integrity of foundational visual processing impacts reading through a sequential chain reaction flowing from visual attention to working memory.
To test the model, investigators will employ a rigorous, assessor-blind randomized controlled trial with 100 Cantonese-speaking children with developmental dyslexia. Participants will be randomly assigned to either an intervention group that plays action video games, scientifically proven to enhance visual attention, or an active control group that plays a different type of non-action, engaging game. This design allows investigators to isolate the specific impact of the visual-attentional training. The investigators will track changes at four time points-before, during, immediately after the intervention, and at a 6-month follow-up-using a multi-level assessment battery, including objective neural signals of visual processing, cognitive skills, and real-world reading performance measured with advanced eye-tracking technology.
This research will deliver new knowledge that is both scientifically and socially impactful. It will provide the first causal evidence for a visual-attentional pathway to reading remediation in Chinese developmental dyslexia, fundamentally shifting theoretical understanding of the disorder from a single, phonological deficit to a more comprehensive, multi-component model. The findings will have a significant translational impact, paving the way for innovative, non-reading-based interventions and new early screening tools. Ultimately, this project will offer a new, evidence-based approach to help children overcome the specific neurocognitive bottlenecks that hinder their ability to learn to read, with the potential to improve educational outcomes for a large and underserved population.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Tsz Wing Leung, PhD
- Numéro de téléphone: +852 27664268
- E-mail: jeffrey.TW.leung@polyu.edu.hk
Lieux d'étude
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Hong Kong, Hong Kong
- Recrutement
- Optometry Research Clinic
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Contact:
- Tsz Wing Leung, PhD
- Numéro de téléphone: +852 27664268
- E-mail: jeffrey.TW.leung@polyu.edu.hk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- Formal diagnosis of dyslexia by an educational or clinical psychologist using the Hong Kong Test of Specific Learning Difficulties in Reading and Writing (HKT-SpLD),39 with a literacy composite score at or below the 10th percentile.
- Non-verbal IQ score ≥ 85 on Raven's Standard Progressive Matrices.
- Normal or corrected-to-normal vision (both eyes logMAR 0.1 or better).
Exclusion Criteria:
History of neurological or psychiatric disorders (e.g., epilepsy, psychosis).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Action Video Game (AVG) Intervention Group
Participants will undergo 12 hours of training with a commercially available AVG (Rabbids: Party of Legends).
The game consists of numerous fast-paced mini-games in which players track multiple objects, respond to unpredictable events, and filter out distractions, thereby placing high demands on visual-spatial attention and attentional control.
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Participants will undergo 12 hours of training with a commercially available AVG (Rabbids: Party of Legends).
This game is a direct successor to the Rayman Raving Rabbids game used in AVG intervention studies and shares its core mechanics.
The game consists of numerous fast-paced mini-games in which players track multiple objects, respond to unpredictable events, and filter out distractions, thereby placing high demands on visual-spatial attention and attentional control.
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Comparateur factice: Active Control (Non-Action Video Game) Group
Using a commercially available city-building and management simulation game (e.g., SimCity), which is engaging and cognitively demanding (requiring planning and resource management).
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Participants will undergo 12 hours of training with SimCity.
To control for non-specific effects (e.g., gaming time, engagement, motivation), this group will play a non-action video game of matched duration and format.
The investigators will use a commercially available city-building and management simulation game (e.g., SimCity), which is engaging and cognitively demanding (requiring planning and resource management).
However, it critically lacks the fast, unpredictable, and attention-intensive elements of action games, ensuring that any observed group differences can be attributed specifically to the visual-attentional training provided by the AVG.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Visual Attention Span
Délai: Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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Cued Number Identification Task: This task assesses the rapid deployment of visual attention.
A string of five numbers (Geneva font, size 24, 98% contrast) is presented for 200 ms, followed by a 50-ms visual cue 1 cm beneath the target number.
Numbers are spaced to subtend a 3.8° visual angle and minimise lateral masking.
The child's task is to verbally report the cued number.
The primary metric is the number of correctly reported targets out of 20 trials.
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Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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Verbal Backward Digit Span
Délai: Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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An experimenter reads a sequence of numbers aloud (e.g., '8-2-5') and the child must mentally reverse the sequence and repeat it back ('5-2-8').
The sequence length progressively increases, placing increasing demands on both the storage and manipulation components of working memory.
The score is the number of correctly recalled sequences.
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Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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Coherent Motion Detection
Délai: Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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This task measures motion processing sensitivity using a random-dot kinematogram.
Stimuli consist of 250 white dots (0.2° diameter; 50 cd/m²) moving at 0.24°/sec within a 5° circular aperture against a dark background (0.02 cd/m²).
During each 400-ms trial, a percentage of 'signal' dots move coherently left or right.
The task is to indicate the direct of the 'signal' dots.
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Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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Steady-State Visual Evoked Potentials (ssVEP)
Délai: Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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Participants will view vertically oriented, sinusoidal gratings at 90% contrast.
To target the magnocellular pathway, we will use low spatial frequency (SF) gratings of 0.6 cycles/degree, with high-SF gratings of 6.0 cycles/degree as a control.
Both stimuli will phase-reverse at 7.5 Hz, generating a dominant 15 Hz ssVEP response.
Although fully isolating the parvo- and magnocellular pathways is difficult, this combination of low spatial and high temporal frequency aims to produce a stronger activation of the magnocellular visual pathway.
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Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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Silent Reading and Eye Movement
Délai: Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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Task: Participants will silently read 20 sentences constructed from age-appropriate, high-frequency Chinese characters (font: 'Free HK Kai', recommended by the Education Bureau). Each 18-character sentence spans two lines, with characters subtending a 2° visual angle. To ensure comprehension, a multiple-choice question will follow each sentence. Acquisition: Participants will be seated 50 cm from the screen with a forehead rest for stability. Eye movements will be recorded using a Tobii Pro Fusion eye-tracker (250 Hz sampling rate) following a successful nine-point calibration. Global Reading Metrics: Reading speed (characters per minute) and comprehension accuracy (%). Eye-Movement Metrics: Mean fixation duration, mean saccade length, and number of regressions |
Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Trouble d'apprentissage spécifique
- Manifestations neurologiques
- Maladies du système nerveux
- Les troubles mentaux
- Manifestations neurocomportementales
- Troubles neurodéveloppementaux
- Troubles de la communication
- Troubles du langage
- Des troubles d'apprentissage
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Dyslexie
- Caractéristiques de la population
- Démographie
- Groupes de population
Autres numéros d'identification d'étude
- HSEARS20251111001
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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