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Brain Stimulation With Combined Reading and Motor Training for Children With Dyslexia

21 août 2026 mis à jour par: Mohammad Amin Javedanfar, Shahid Beheshti University

Effectiveness of Dual-Site tDCS Combined With Integrated Phonological and Fine Motor Intervention in 9-Year-Old Boys With Developmental Dyslexia: A Randomized, Double-Blind, Sham-Controlled Trial

This study examines whether combining non-invasive brain stimulation (tDCS) with an integrated reading-and-motor training program improves reading and phonological processing in 9-year-old boys with developmental dyslexia.

Children with dyslexia often have difficulties in phonological awareness and fine motor skills. This study targets two brain areas at the same time: the left temporoparietal junction (important for reading and phonological processing) and the left primary motor cortex (important for hand movements and speech-related motor processes).

Participants will be randomly assigned to one of eight groups. Some groups will receive active brain stimulation, and some will receive sham (inactive) stimulation, while also participating in different types of training: phonological awareness training, fine motor training, combined phonological and fine motor training, or no training. The treatment includes 20 sessions, three times per week for about 7 weeks.

Reading and phonological skills will be measured before treatment, immediately after treatment, and again 3 months and 6 months later. The study will help determine whether a full treatment package-using brain stimulation together with combined reading and motor training-is more effective than single treatments or usual school education.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

This is a randomized, double-blind, sham-controlled, 8-group component trial in 9-year-old boys with developmental dyslexia. The study tests a theory-driven prediction derived from multiple-deficit models of dyslexia: that simultaneously targeting reading-related and sensory-motor brain networks, while delivering an integrated phonological and fine motor intervention, produces greater and more durable reading improvement than single-component interventions.

The tDCS protocol uses 1 mA current for 20 minutes per session over 20 sessions (3 sessions/week). Electrode montages are yoked to the type of cognitive intervention: left temporoparietal (TPJ) for phonological training, left primary motor cortex (M1) for motor training, and dual-site TPJ+M1 for the combined intervention. A tDCS-only group (M1 montage) is included to isolate the effect of motor cortex stimulation.

Primary outcome: change in the composite score of Factor 1 of the Reading and Dyslexia Test (word reading, phoneme deletion, nonword reading, and word comprehension). Secondary outcomes: fine motor performance (BOT-2), rapid automatized naming, and text reading fluency.

Assessments occur at baseline, immediately after the intervention, and at 3- and 6-month follow-ups.

Type d'étude

Interventionnel

Inscription (Estimé)

160

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • L'Iran
    • Isfahan
      • Isfahan, Isfahan, L'Iran, 8155113853
        • Consultation, Psychological, Research and Specialized Services Center of Isfahan Province General Department of Education
        • Contact:
        • Sous-enquêteur:
          • Mohammad Amin Javedanfar, MSc

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Male children aged 9 years (9 years 0 months to 9 years 11 months) with developmental dyslexia diagnosed according to DSM-5 criteria by a clinical team.
  • Reading and Dyslexia Test (NAMA) T score ≤ 30 (at least 2 standard deviations below the mean).
  • Full Scale IQ ≥ 85 on the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V).
  • Score below 88 on the Spence Children's Anxiety Scale (SCAS).
  • Fine motor deficits defined as standard score ≤ 40 on Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) manual dexterity and upper-limb coordination subtests.
  • Normal or corrected-to-normal vision and hearing.
  • No history of seizure or epilepsy, no scalp skin disease, no cochlear implant, cardiac pacemaker, or metal implants in the skull.
  • Written informed consent from parents or legal guardian and verbal assent from the child.

Exclusion Criteria:

  • Intellectual disability (Full Scale IQ < 85).
  • Personal history of epilepsy or seizure disorder, or epilepsy in a first-degree relative.
  • Presence of cochlear implant, cardiac pacemaker, or metal implants in the skull.
  • Skin diseases or open lesions on the scalp at electrode sites.
  • Uncorrected visual or hearing impairments.
  • Other primary psychiatric or neurodevelopmental disorders requiring ongoing treatment (e.g., ADHD, autism spectrum disorder, severe anxiety disorder).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur factice: Control (Sham + Usual School)
Sham tDCS randomly selected montage + usual school education, no cognitive training
Dispositif: Sham transcranial direct current stimulation (tDCS)
Sham tDCS will use the same electrode positions as the active groups, but the current will be applied for only 30 seconds and then gradually ramped down.
Autres noms:
  • TDCS factice
Autre: Usual school education
Participants receive the standard school curriculum without additional cognitive or motor training.
Comparateur factice: Sham-PA
Sham tDCS TPJ + phonological awareness training
Dispositif: Sham transcranial direct current stimulation (tDCS)
Sham tDCS will use the same electrode positions as the active groups, but the current will be applied for only 30 seconds and then gradually ramped down.
Autres noms:
  • TDCS factice
Comportemental: Phonological awareness training
20 sessions of 60 minutes each, three times per week for about 7 weeks. Covers syllable segmentation, rhyme, phoneme blending and segmentation, initial and final phoneme identification, phoneme manipulation, and grapheme-to-phoneme mapping.
Autres noms:
  • PA training
Comparateur factice: Sham-Motor
Sham tDCS M1 + non-targeted fine motor training
Dispositif: Sham transcranial direct current stimulation (tDCS)
Sham tDCS will use the same electrode positions as the active groups, but the current will be applied for only 30 seconds and then gradually ramped down.
Autres noms:
  • TDCS factice
Comportemental: Non-targeted fine motor training
20 sessions of 60 minutes each, three times per week for about 7 weeks. Includes activities without linguistic content, such as free play with dough, bead threading, pegboard tasks, and other manual dexterity exercises.
Autres noms:
  • Fine motor training
Comparateur factice: Sham-Comb
Sham dual-channel TPJ+M1 + combined phonological and fine motor intervention
Dispositif: Sham transcranial direct current stimulation (tDCS)
Sham tDCS will use the same electrode positions as the active groups, but the current will be applied for only 30 seconds and then gradually ramped down.
Autres noms:
  • TDCS factice
Comportemental: Integrated phonological and fine motor intervention
20 sessions of 60 minutes each, three times per week for about 7 weeks. Combines phonological awareness training with targeted fine motor activities linked to reading, such as forming letters with dough and stringing beads marked with phonemes.
Autres noms:
  • Combined intervention
Expérimental: Active-PA
Active tDCS TPJ + phonological awareness training
Comportemental: Phonological awareness training
20 sessions of 60 minutes each, three times per week for about 7 weeks. Covers syllable segmentation, rhyme, phoneme blending and segmentation, initial and final phoneme identification, phoneme manipulation, and grapheme-to-phoneme mapping.
Autres noms:
  • PA training
Dispositif: Active transcranial direct current stimulation (tDCS)
Active tDCS will be delivered at 1 milliampere for 20 minutes per session, 20 sessions over about 7 weeks. The montage varies by arm: left temporoparietal (TPJ) montage, left primary motor cortex (M1) montage, or dual-site TPJ+M1 montage.
Autres noms:
  • tDCS
Expérimental: Active-Motor
Active tDCS M1 + non-targeted fine motor training
Comportemental: Non-targeted fine motor training
20 sessions of 60 minutes each, three times per week for about 7 weeks. Includes activities without linguistic content, such as free play with dough, bead threading, pegboard tasks, and other manual dexterity exercises.
Autres noms:
  • Fine motor training
Dispositif: Active transcranial direct current stimulation (tDCS)
Active tDCS will be delivered at 1 milliampere for 20 minutes per session, 20 sessions over about 7 weeks. The montage varies by arm: left temporoparietal (TPJ) montage, left primary motor cortex (M1) montage, or dual-site TPJ+M1 montage.
Autres noms:
  • tDCS
Expérimental: Active-Comb
Active dual-site TPJ+M1 + combined phonological and fine motor intervention
Comportemental: Integrated phonological and fine motor intervention
20 sessions of 60 minutes each, three times per week for about 7 weeks. Combines phonological awareness training with targeted fine motor activities linked to reading, such as forming letters with dough and stringing beads marked with phonemes.
Autres noms:
  • Combined intervention
Dispositif: Active transcranial direct current stimulation (tDCS)
Active tDCS will be delivered at 1 milliampere for 20 minutes per session, 20 sessions over about 7 weeks. The montage varies by arm: left temporoparietal (TPJ) montage, left primary motor cortex (M1) montage, or dual-site TPJ+M1 montage.
Autres noms:
  • tDCS
Expérimental: Active-Only
Active tDCS M1 alone, no cognitive intervention
Dispositif: Active transcranial direct current stimulation (tDCS)
Active tDCS will be delivered at 1 milliampere for 20 minutes per session, 20 sessions over about 7 weeks. The montage varies by arm: left temporoparietal (TPJ) montage, left primary motor cortex (M1) montage, or dual-site TPJ+M1 montage.
Autres noms:
  • tDCS

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Composite score of Factor 1 of the Reading and Dyslexia Test (NAMA)
Délai: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
Composite score of Factor 1 of the Reading and Dyslexia Test, which includes word reading, phoneme deletion, nonword reading, and word comprehension subtests.
Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Fine motor performance (BOT-2 manual dexterity and upper-limb coordination)
Délai: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
Fine motor performance as measured by the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, manual dexterity and upper-limb coordination subtests. Raw scores of the common items will be used for longitudinal comparison.
Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
Rapid automatized naming speed
Délai: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
Rapid automatized naming speed, including naming of objects, colors, numbers, and letters. The total time in seconds to name each card is recorded.
Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
Text reading fluency (correct words per minute)
Délai: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
Text reading fluency defined as the number of correct words read per minute on a grade-level reading passage. Correct words per minute will be calculated as the total number of words minus errors, multiplied by 60, divided by the total reading time in seconds.
Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Shahid Beheshti University

Les enquêteurs

  • Chaise d'étude: Shahriar Gharibzadeh, Ph.D., Institute for Cognitive and Brain Sciences, Shahid Beheshti University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

23 août 2026

Achèvement primaire (Estimé)

6 juillet 2027

Achèvement de l'étude (Estimé)

1 août 2027

Dates d'inscription aux études

Première soumission

20 août 2026

Première soumission répondant aux critères de contrôle qualité

20 août 2026

Première publication (Réel)

24 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SBU-tDCS-Dyslexia-001
  • IRCT20260817070696N1 (Identificateur de registre: Iranian Registry of Clinical Trials)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be shared due to confidentiality and ethical considerations related to minor participants. Sharing of participant-level data was not included in the informed consent or the study ethics approval. Only aggregate, deidentified results will be reported.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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