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

21 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

160

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Iran
    • Isfahan
      • Isfahan, Isfahan, Iran, 8155113853
        • Consultation, Psychological, Research and Specialized Services Center of Isfahan Province General Department of Education
        • Contact:
        • Onderonderzoeker:
          • Mohammad Amin Javedanfar, MSc

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Sham-vergelijker: Control (Sham + Usual School)
Sham tDCS randomly selected montage + usual school education, no cognitive training
Apparaat: 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.
Andere namen:
  • Sham tDCS
Ander: Usual school education
Participants receive the standard school curriculum without additional cognitive or motor training.
Sham-vergelijker: Sham-PA
Sham tDCS TPJ + phonological awareness training
Apparaat: 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.
Andere namen:
  • Sham tDCS
Gedragsmatig: 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.
Andere namen:
  • PA training
Sham-vergelijker: Sham-Motor
Sham tDCS M1 + non-targeted fine motor training
Apparaat: 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.
Andere namen:
  • Sham tDCS
Gedragsmatig: 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.
Andere namen:
  • Fine motor training
Sham-vergelijker: Sham-Comb
Sham dual-channel TPJ+M1 + combined phonological and fine motor intervention
Apparaat: 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.
Andere namen:
  • Sham tDCS
Gedragsmatig: 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.
Andere namen:
  • Combined intervention
Experimenteel: Active-PA
Active tDCS TPJ + phonological awareness training
Gedragsmatig: 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.
Andere namen:
  • PA training
Apparaat: 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.
Andere namen:
  • tDCS
Experimenteel: Active-Motor
Active tDCS M1 + non-targeted fine motor training
Gedragsmatig: 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.
Andere namen:
  • Fine motor training
Apparaat: 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.
Andere namen:
  • tDCS
Experimenteel: Active-Comb
Active dual-site TPJ+M1 + combined phonological and fine motor intervention
Gedragsmatig: 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.
Andere namen:
  • Combined intervention
Apparaat: 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.
Andere namen:
  • tDCS
Experimenteel: Active-Only
Active tDCS M1 alone, no cognitive intervention
Apparaat: 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.
Andere namen:
  • tDCS

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Composite score of Factor 1 of the Reading and Dyslexia Test (NAMA)
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fine motor performance (BOT-2 manual dexterity and upper-limb coordination)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shahid Beheshti University

Onderzoekers

  • Studie stoel: Shahriar Gharibzadeh, Ph.D., Institute for Cognitive and Brain Sciences, Shahid Beheshti University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

23 augustus 2026

Primaire voltooiing (Geschat)

6 juli 2027

Studie voltooiing (Geschat)

1 augustus 2027

Studieregistratiedata

Eerst ingediend

20 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 augustus 2026

Eerst geplaatst (Werkelijk)

24 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

21 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SBU-tDCS-Dyslexia-001
  • IRCT20260817070696N1 (Register-ID: Iranian Registry of Clinical Trials)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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