Brain Stimulation With Combined Reading and Motor Training for Children With Dyslexia
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.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
- Device: Sham transcranial direct current stimulation (tDCS)
- Other: Usual school education
- Behavioral: Phonological awareness training
- Behavioral: Non-targeted fine motor training
- Behavioral: Integrated phonological and fine motor intervention
- Device: Active transcranial direct current stimulation (tDCS)
Detailed Description
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.
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Mohammad Amin Javedanfar, MSc
- Phone Number: +98 21 2990 2761
- Email: m_javedanfar@sbu.ac.ir
Study Locations
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Isfahan
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Isfahan, Isfahan, Iran, 8155113853
- Consultation, Psychological, Research and Specialized Services Center of Isfahan Province General Department of Education
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Contact:
- Mohammad Amin Javedanfar, MSc
- Phone Number: +98 31 3265 5530
- Email: m_javedanfar@sbu.ac.ir
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Sub-Investigator:
- Mohammad Amin Javedanfar, MSc
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Sham Comparator: 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.
Other Names:
Participants receive the standard school curriculum without additional cognitive or motor training.
|
|
Sham Comparator: Sham-PA
Sham tDCS TPJ + phonological awareness training
|
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.
Other Names:
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.
Other Names:
|
|
Sham Comparator: Sham-Motor
Sham tDCS M1 + non-targeted fine motor training
|
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.
Other Names:
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.
Other Names:
|
|
Sham Comparator: Sham-Comb
Sham dual-channel TPJ+M1 + combined phonological and fine motor intervention
|
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.
Other Names:
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.
Other Names:
|
|
Experimental: Active-PA
Active tDCS TPJ + 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.
Other Names:
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.
Other Names:
|
|
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.
Other Names:
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.
Other Names:
|
|
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.
Other Names:
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.
Other Names:
|
|
Experimental: Active-Only
Active tDCS M1 alone, no cognitive intervention
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite score of Factor 1 of the Reading and Dyslexia Test (NAMA)
Time Frame: 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.
|
Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fine motor performance (BOT-2 manual dexterity and upper-limb coordination)
Time Frame: 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
Time Frame: 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.
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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)
Time Frame: 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.
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Chair: Shahriar Gharibzadeh, Ph.D., Institute for Cognitive and Brain Sciences, Shahid Beheshti University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Specific Learning Disorder
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Communication Disorders
- Language Disorders
- Learning Disabilities
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Dyslexia
- Therapeutics
- Behavioral Disciplines and Activities
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
Other Study ID Numbers
Other Study ID Numbers
- SBU-tDCS-Dyslexia-001
- IRCT20260817070696N1 (Registry Identifier: Iranian Registry of Clinical Trials)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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