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

21. srpna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

160

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Írán
    • Isfahan
      • Isfahan, Isfahan, Írán, 8155113853
        • Consultation, Psychological, Research and Specialized Services Center of Isfahan Province General Department of Education
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Mohammad Amin Javedanfar, MSc

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ne

Popis

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).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Falešný srovnávač: Control (Sham + Usual School)
Sham tDCS randomly selected montage + usual school education, no cognitive training
Přístroj: 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.
Ostatní jména:
  • Falešné tDCS
Jiný: Usual school education
Participants receive the standard school curriculum without additional cognitive or motor training.
Falešný srovnávač: Sham-PA
Sham tDCS TPJ + phonological awareness training
Přístroj: 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.
Ostatní jména:
  • Falešné tDCS
Behaviorální: 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.
Ostatní jména:
  • PA training
Falešný srovnávač: Sham-Motor
Sham tDCS M1 + non-targeted fine motor training
Přístroj: 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.
Ostatní jména:
  • Falešné tDCS
Behaviorální: 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.
Ostatní jména:
  • Fine motor training
Falešný srovnávač: Sham-Comb
Sham dual-channel TPJ+M1 + combined phonological and fine motor intervention
Přístroj: 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.
Ostatní jména:
  • Falešné tDCS
Behaviorální: 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.
Ostatní jména:
  • Combined intervention
Experimentální: Active-PA
Active tDCS TPJ + phonological awareness training
Behaviorální: 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.
Ostatní jména:
  • PA training
Přístroj: 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.
Ostatní jména:
  • tDCS
Experimentální: Active-Motor
Active tDCS M1 + non-targeted fine motor training
Behaviorální: 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.
Ostatní jména:
  • Fine motor training
Přístroj: 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.
Ostatní jména:
  • tDCS
Experimentální: Active-Comb
Active dual-site TPJ+M1 + combined phonological and fine motor intervention
Behaviorální: 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.
Ostatní jména:
  • Combined intervention
Přístroj: 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.
Ostatní jména:
  • tDCS
Experimentální: Active-Only
Active tDCS M1 alone, no cognitive intervention
Přístroj: 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.
Ostatní jména:
  • tDCS

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Composite score of Factor 1 of the Reading and Dyslexia Test (NAMA)
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Fine motor performance (BOT-2 manual dexterity and upper-limb coordination)
Časové okno: 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
Časové okno: 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)
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Shahid Beheshti University

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

23. srpna 2026

Primární dokončení (Odhadovaný)

6. července 2027

Dokončení studie (Odhadovaný)

1. srpna 2027

Termíny zápisu do studia

První předloženo

20. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

20. srpna 2026

První zveřejněno (Aktuální)

24. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

25. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • SBU-tDCS-Dyslexia-001
  • IRCT20260817070696N1 (Identifikátor registru: Iranian Registry of Clinical Trials)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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