Developmental DyslexiaNCT07781761
Brain Stimulation With Combined Reading and Motor Training for Children With Dyslexia
A study testing Active transcranial direct current stimulation (tDCS), Phonological awareness training and Non-targeted fine motor training in people with Developmental Dyslexia, run by Shahid Beheshti University at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 108 to 119 months, men only
- Conditions the study is for
- Developmental Dyslexia
- What is being tested?
- Active transcranial direct current stimulation (tDCS), Phonological awareness training and Non-targeted fine motor training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteIran
- Study dates
- 23 Aug 2026to 1 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 108 to 119 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site
Consultation, Psychological, Research and Specialized Services Center of Isfahan Province General Department of Education
Isfahan, Isfahan, 8155113853
Mohammad Amin Javedanfar, MSc, +98 31 3265 5530, m_javedanfar@sbu.ac.ir
Mohammad Amin Javedanfar, MSc
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Developmental Dyslexia
- Being tested
- Active transcranial direct current stimulation (tDCS), Sham transcranial direct current stimulation (tDCS), Phonological awareness training, Non-targeted fine motor training, Integrated phonological and fine motor intervention
- Keywords
- Developmental Dyslexia, tDCS, Phonological Awareness, Fine Motor Training, Reading, Children, Dual-site transcranial direct current stimulation
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcranial direct current stimulation (tDCS)Device
Also called 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.
Sham transcranial direct current stimulation (tDCS)Device
Also called Sham 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.
Phonological awareness trainingBehavioural
Also called PA 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.
Non-targeted fine motor trainingBehavioural
Also called 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.
Integrated phonological and fine motor interventionBehavioural
Also called Combined 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.
Usual school educationOther
Participants receive the standard school curriculum without additional cognitive or motor training.
| Study group | Role | What they receive |
|---|---|---|
| Control (Sham + Usual School) | Sham comparator | Sham tDCS randomly selected montage + usual school education, no cognitive training Receives: Device: Sham transcranial direct current stimulation (tDCS); Other: Usual school education |
| Sham-PA | Sham comparator | Sham tDCS TPJ + phonological awareness training Receives: Device: Sham transcranial direct current stimulation (tDCS); Behavioral: Phonological awareness training |
| Sham-Motor | Sham comparator | Sham tDCS M1 + non-targeted fine motor training Receives: 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 Receives: Device: Sham transcranial direct current stimulation (tDCS); Behavioral: Integrated phonological and fine motor intervention |
| Active-PA | Experimental | Active tDCS TPJ + phonological awareness training Receives: Device: Active transcranial direct current stimulation (tDCS); Behavioral: Phonological awareness training |
| Active-Motor | Experimental | Active tDCS M1 + non-targeted fine motor training Receives: 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 Receives: Device: Active transcranial direct current stimulation (tDCS); Behavioral: Integrated phonological and fine motor intervention |
| Active-Only | Experimental | Active tDCS M1 alone, no cognitive intervention Receives: Device: Active transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
Rapid automatized naming speed
Rapid automatized naming speed, including naming of objects, colors, numbers, and letters. The total time in seconds to name each card is recorded.
Measured: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
Text reading fluency (correct words per minute)
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.
Measured: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start23 Aug 2026 (estimated)
- Primary completion6 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DyslexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Amin Javedanfar, Shahid Beheshti University
- Investigators
- Shahriar Gharibzadeh, Ph.D., Study chair, Institute for Cognitive and Brain Sciences, Shahid Beheshti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781761
- Sponsor's protocol ID
- SBU-tDCS-Dyslexia-001
- Other IDs
- IRCT20260817070696N1
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.