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

21. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

160

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Schein-Komparator: Control (Sham + Usual School)
Sham tDCS randomly selected montage + usual school education, no cognitive training
Gerät: 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:
  • Schein-tDCS
Sonstiges: Usual school education
Participants receive the standard school curriculum without additional cognitive or motor training.
Schein-Komparator: Sham-PA
Sham tDCS TPJ + phonological awareness training
Gerät: 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:
  • Schein-tDCS
Verhalten: 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
Schein-Komparator: Sham-Motor
Sham tDCS M1 + non-targeted fine motor training
Gerät: 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:
  • Schein-tDCS
Verhalten: 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
Schein-Komparator: Sham-Comb
Sham dual-channel TPJ+M1 + combined phonological and fine motor intervention
Gerät: 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:
  • Schein-tDCS
Verhalten: 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
Experimental: Active-PA
Active tDCS TPJ + phonological awareness training
Verhalten: 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
Gerät: 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
Experimental: Active-Motor
Active tDCS M1 + non-targeted fine motor training
Verhalten: 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
Gerät: 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
Experimental: Active-Comb
Active dual-site TPJ+M1 + combined phonological and fine motor intervention
Verhalten: 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
Gerät: 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
Experimental: Active-Only
Active tDCS M1 alone, no cognitive intervention
Gerät: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Composite score of Factor 1 of the Reading and Dyslexia Test (NAMA)
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Fine motor performance (BOT-2 manual dexterity and upper-limb coordination)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Shahid Beheshti University

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

23. August 2026

Primärer Abschluss (Geschätzt)

6. Juli 2027

Studienabschluss (Geschätzt)

1. August 2027

Studienanmeldedaten

Zuerst eingereicht

20. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. August 2026

Zuerst gepostet (Tatsächlich)

24. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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