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

21 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

160

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Iran
    • Isfahan
      • Isfahan, Isfahan, Iran, 8155113853
        • Consultation, Psychological, Research and Specialized Services Center of Isfahan Province General Department of Education
        • Kontakt:
        • Pod-śledczy:
          • Mohammad Amin Javedanfar, MSc

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Pozorny komparator: Control (Sham + Usual School)
Sham tDCS randomly selected montage + usual school education, no cognitive training
Urządzenie: 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.
Inne nazwy:
  • Fałsz tDCS
Inny: Usual school education
Participants receive the standard school curriculum without additional cognitive or motor training.
Pozorny komparator: Sham-PA
Sham tDCS TPJ + phonological awareness training
Urządzenie: 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.
Inne nazwy:
  • Fałsz tDCS
Behawioralne: 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.
Inne nazwy:
  • PA training
Pozorny komparator: Sham-Motor
Sham tDCS M1 + non-targeted fine motor training
Urządzenie: 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.
Inne nazwy:
  • Fałsz tDCS
Behawioralne: 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.
Inne nazwy:
  • Fine motor training
Pozorny komparator: Sham-Comb
Sham dual-channel TPJ+M1 + combined phonological and fine motor intervention
Urządzenie: 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.
Inne nazwy:
  • Fałsz tDCS
Behawioralne: 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.
Inne nazwy:
  • Combined intervention
Eksperymentalny: Active-PA
Active tDCS TPJ + phonological awareness training
Behawioralne: 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.
Inne nazwy:
  • PA training
Urządzenie: 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.
Inne nazwy:
  • tDCS
Eksperymentalny: Active-Motor
Active tDCS M1 + non-targeted fine motor training
Behawioralne: 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.
Inne nazwy:
  • Fine motor training
Urządzenie: 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.
Inne nazwy:
  • tDCS
Eksperymentalny: Active-Comb
Active dual-site TPJ+M1 + combined phonological and fine motor intervention
Behawioralne: 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.
Inne nazwy:
  • Combined intervention
Urządzenie: 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.
Inne nazwy:
  • tDCS
Eksperymentalny: Active-Only
Active tDCS M1 alone, no cognitive intervention
Urządzenie: 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.
Inne nazwy:
  • tDCS

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Composite score of Factor 1 of the Reading and Dyslexia Test (NAMA)
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Fine motor performance (BOT-2 manual dexterity and upper-limb coordination)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Shahid Beheshti University

Śledczy

  • Krzesło do nauki: Shahriar Gharibzadeh, Ph.D., Institute for Cognitive and Brain Sciences, Shahid Beheshti University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

23 sierpnia 2026

Zakończenie podstawowe (Szacowany)

6 lipca 2027

Ukończenie studiów (Szacowany)

1 sierpnia 2027

Daty rejestracji na studia

Pierwszy przesłany

20 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

24 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • SBU-tDCS-Dyslexia-001
  • IRCT20260817070696N1 (Identyfikator rejestru: Iranian Registry of Clinical Trials)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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