Brain Stimulation With Combined Reading and Motor Training for Children With Dyslexia
21 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
- Dispositivo: Sham transcranial direct current stimulation (tDCS)
- Otro: Usual school education
- Conductual: Phonological awareness training
- Conductual: Non-targeted fine motor training
- Conductual: Integrated phonological and fine motor intervention
- Dispositivo: Active transcranial direct current stimulation (tDCS)
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
160
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Mohammad Amin Javedanfar, MSc
- Número de teléfono: +98 21 2990 2761
- Correo electrónico: m_javedanfar@sbu.ac.ir
Ubicaciones de estudio
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Isfahan
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Isfahan, Isfahan, Irán, 8155113853
- Consultation, Psychological, Research and Specialized Services Center of Isfahan Province General Department of Education
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Contacto:
- Mohammad Amin Javedanfar, MSc
- Número de teléfono: +98 31 3265 5530
- Correo electrónico: m_javedanfar@sbu.ac.ir
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Sub-Investigador:
- Mohammad Amin Javedanfar, MSc
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador falso: Control (Sham + Usual School)
Sham tDCS randomly selected montage + usual school education, no cognitive training
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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.
Otros nombres:
Participants receive the standard school curriculum without additional cognitive or motor training.
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Comparador falso: Sham-PA
Sham tDCS TPJ + phonological awareness training
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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.
Otros nombres:
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.
Otros nombres:
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Comparador falso: Sham-Motor
Sham tDCS M1 + non-targeted fine motor training
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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.
Otros nombres:
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.
Otros nombres:
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Comparador falso: Sham-Comb
Sham dual-channel TPJ+M1 + combined phonological and fine motor intervention
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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.
Otros nombres:
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.
Otros nombres:
|
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Experimental: Active-PA
Active tDCS TPJ + phonological awareness training
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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.
Otros nombres:
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.
Otros nombres:
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Experimental: Active-Motor
Active tDCS M1 + 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.
Otros nombres:
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.
Otros nombres:
|
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Experimental: Active-Comb
Active dual-site TPJ+M1 + combined 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.
Otros nombres:
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.
Otros nombres:
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Experimental: Active-Only
Active tDCS M1 alone, no cognitive intervention
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Composite score of Factor 1 of the Reading and Dyslexia Test (NAMA)
Periodo de tiempo: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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Composite score of Factor 1 of the Reading and Dyslexia Test, which includes word reading, phoneme deletion, nonword reading, and word comprehension subtests.
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Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fine motor performance (BOT-2 manual dexterity and upper-limb coordination)
Periodo de tiempo: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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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.
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Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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Rapid automatized naming speed
Periodo de tiempo: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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Rapid automatized naming speed, including naming of objects, colors, numbers, and letters.
The total time in seconds to name each card is recorded.
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Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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Text reading fluency (correct words per minute)
Periodo de tiempo: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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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.
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Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Shahriar Gharibzadeh, Ph.D., Institute for Cognitive and Brain Sciences, Shahid Beheshti University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
23 de agosto de 2026
Finalización primaria (Estimado)
6 de julio de 2027
Finalización del estudio (Estimado)
1 de agosto de 2027
Fechas de registro del estudio
Enviado por primera vez
20 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2026
Publicado por primera vez (Actual)
24 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastorno Específico del Aprendizaje
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Manifestaciones neuroconductuales
- Trastornos del neurodesarrollo
- Desordenes comunicacionales
- Trastornos del lenguaje
- Dificultades de aprendizaje
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dislexia
- Terapéutica
- Disciplinas y actividades de comportamiento
- Terapia de estimulación eléctrica
- Terapia convulsiva
- Terapias somáticas psiquiátricas
- Electrochoque
- Técnicas psicológicas
- Estimulación de corriente continua transcraneal
Otros números de identificación del estudio
- SBU-tDCS-Dyslexia-001
- IRCT20260817070696N1 (Identificador de registro: Iranian Registry of Clinical Trials)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .