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

NCT07781761 | Not Yet Recruiting DMC

• 2 other identifiers: SBU-tDCS-Dyslexia-001IRCT20260817070696N1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Developmental Dyslexia

Keywords

Developmental Dyslexia; tDCS; Phonological Awareness; Fine Motor Training; Reading; Children; Dual-site transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Composite score of Factor 1 of the Reading and Dyslexia Test (NAMA)

  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.

Secondary Outcomes (3)

• Fine motor performance (BOT-2 manual dexterity and upper-limb coordination)

  Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.

• Rapid automatized naming speed

  Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.

• Text reading fluency (correct words per minute)

  Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.

Study Arms (8)

Control (Sham + Usual School)

SHAM COMPARATOR

Sham tDCS randomly selected montage + usual school education, no cognitive training

Device: Sham transcranial direct current stimulation (tDCS); Other: Usual school education

Sham-PA

SHAM COMPARATOR

Sham tDCS TPJ + phonological awareness training

Device: Sham transcranial direct current stimulation (tDCS); Behavioral: Phonological awareness training

Sham-Motor

SHAM COMPARATOR

Sham tDCS M1 + non-targeted fine motor training

Device: Sham transcranial direct current stimulation (tDCS); Behavioral: Non-targeted fine motor training

Sham-Comb

SHAM COMPARATOR

Sham dual-channel TPJ+M1 + combined phonological and fine motor intervention

Device: Sham transcranial direct current stimulation (tDCS); Behavioral: Integrated phonological and fine motor intervention

Active-PA

EXPERIMENTAL

Active tDCS TPJ + phonological awareness training

Device: Active transcranial direct current stimulation (tDCS); Behavioral: Phonological awareness training

Active-Motor

EXPERIMENTAL

Active tDCS M1 + non-targeted fine motor training

Device: Active transcranial direct current stimulation (tDCS); Behavioral: Non-targeted fine motor training

Active-Comb

EXPERIMENTAL

Active dual-site TPJ+M1 + combined phonological and fine motor intervention

Device: Active transcranial direct current stimulation (tDCS); Behavioral: Integrated phonological and fine motor intervention

Active-Only

EXPERIMENTAL

Active tDCS M1 alone, no cognitive intervention

Device: Active transcranial direct current stimulation (tDCS)

Interventions

Active transcranial direct current stimulation (tDCS) DEVICE

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.

Also known as: tDCS

Active-Comb; Active-Motor; Active-Only; Active-PA

Sham transcranial direct current stimulation (tDCS) DEVICE

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.

Also known as: Sham tDCS

Control (Sham + Usual School); Sham-Comb; Sham-Motor; Sham-PA

Phonological awareness training BEHAVIORAL

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.

Also known as: PA training

Active-PA; Sham-PA

Non-targeted fine motor training BEHAVIORAL

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.

Also known as: Fine motor training

Active-Motor; Sham-Motor

Integrated phonological and fine motor intervention BEHAVIORAL

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.

Also known as: Combined intervention

Active-Comb; Sham-Comb

Usual school education OTHER

Participants receive the standard school curriculum without additional cognitive or motor training.

Control (Sham + Usual School)

Eligibility Criteria

• Age: 108 Months - 119 Months
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shahid Beheshti University: lead

Study Sites (1)

Consultation, Psychological, Research and Specialized Services Center of Isfahan Province General Department of Education

Isfahan, Isfahan, 8155113853, Iran

Location

Related Links

• Iranian Registry of Clinical Trials (IRCT) record

MeSH Terms

Conditions

Dyslexia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Shahriar Gharibzadeh, Ph.D.

  Institute for Cognitive and Brain Sciences, Shahid Beheshti University

  STUDY CHAIR

Central Study Contacts

Mohammad Amin Javedanfar, MSc

CONTACT

+98 21 2990 2761; m_javedanfar@sbu.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Cognitive therapists are also blinded. The tDCS operator is the only unblinded person and has no role in cognitive training or outcome assessment. Data analysts are blinded until the primary analyses are completed. The Data Safety and Monitoring Board may be unblinded as needed for safety monitoring.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Eight-arm component design. The tDCS montage is yoked to the type of cognitive intervention (TPJ for phonological training, M1 for motor training, dual-site TPJ+M1 for the combined intervention). Not all possible montage × training combinations are evaluated; therefore, this is not a complete factorial design.

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: August 23, 2026
• Primary Completion (Estimated): July 6, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)