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IRCT20260817070696N1 IRCT 2026-08-20 Shahid Beheshti University Brain stimulation with combined reading and motor training for children with dyslexia Effectiveness of simultaneous dual-site transcranial direct current stimulation combined with integrated phonological and fine motor intervention compared with single interventions and sham in improving reading and phonological processing in 9-year-old boys with developmental dyslexia: a randomized, double-blind, sham-controlled trial 2026-08-23 anticipated 160 Recruiting https://irct.ir/trial/92619 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This will be an 8-group, theory-driven component trial (not a complete factorial design). The tDCS montage will be yoked to the type of cognitive intervention: TPJ stimulation for phonological training, M1 stimulation for motor training, and dual-site stimulation for the combined intervention. The combined intervention group will receive simultaneous two-channel tDCS and online cognitive training. A tDCS-only group (M1 montage) will be included to isolate the effect of motor cortex stimulation. Four assessment time points will be used: baseline, post-test, 3-month follow-up, and 6-month follow-up, Randomization description: Randomization will be performed using block randomization with a block size of 8. The unit of randomization will be the individual participant. A web-based random sequence generator (www.randomlists.com) will be used to create the allocation sequence. No stratification factors will be applied. Allocation concealment will be ensured by placing the allocation sequence in sequentially numbered, sealed, opaque envelopes. An independent research assistant who will not be involved in outcome assessment or intervention delivery will open the envelope at the time of each participant's enrollment and will assign the participant to the corresponding group, Blinding description: Participants and their parents will be blinded to whether they receive active or sham tDCS. Outcome assessors and therapists delivering cognitive interventions will also be blinded. The tDCS operator will be the only unblinded person and will have no role in outcome assessment or cognitive training. Data analysts will be blinded to group labels until the primary analyses are completed. To reduce the initial tingling sensation and improve blinding, a topical local anesthetic (6% benzocaine) will be applied before electrode placement. A Data Safety and Monitoring Board (DSMB) will be unblinded as needed for safety monitoring. N/A Developmental dyslexia. Intervention 1: Control group: Participants will receive usual school education plus sham transcranial direct current stimulation. The sham stimulation 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. For the control group, the sham montage will be randomly selected from the three main montages and will remain fixed across all 20 sessions. Sessions will be conducted three times per week for approximately seven weeks. Intervention 2: Intervention group 1: sham transcranial direct current stimulation with the anode over the left temporoparietal junction and the cathode over the right temporoparietal junction, plus phonological awareness training. Sham stimulation will be applied for only 30 seconds. Phonological awareness training will be delivered in 20 sessions of 60 minutes each, three times per week for about 7 weeks, and will cover syllable segmentation, rhyme, phoneme blending and segmentation, initial and final phoneme identification, phoneme manipulation, and grapheme-to-phoneme mapping. Intervention 3: Intervention group 2: sham transcranial direct current stimulation with the anode over the left primary motor cortex and the cathode over the right supraorbital region, plus non-targeted fine motor training. Sham stimulation will be applied for only 30 seconds. Non-targeted fine motor training will include activities without linguistic content, such as free play with dough, bead threading, pegboard tasks, and other manual dexterity exercises, delivered in 20 sessions of 60 minutes each, three times per week for about 7 weeks. Intervention 4: Intervention group 3: sham transcranial direct current stimulation with a two-channel montage, including one channel over the temporoparietal junction and one channel over the left primary motor cortex, plus the integrated phonological and fine motor intervention. Sham stimulation will be applied for only 30 seconds on both channels. The integrated intervention will combine phonological awareness training with targeted fine motor activities linked to reading, such as forming letters with dough and stringing beads marked with phonemes, delivered in 20 sessions of 60 minutes each, three times per week for about 7 weeks. Intervention 5: Intervention group 4: active transcranial direct current stimulation with the anode over the left temporoparietal junction and the cathode over the right temporoparietal junction, plus phonological awareness training. Active stimulation will be delivered at 1 milliampere for 20 minutes during the first part of each session, three times per week for 20 sessions over about 7 weeks. Phonological awareness training will be the same as Intervention group 1. Intervention 6: Intervention group 5: active transcranial direct current stimulation with the anode over the left primary motor cortex and the cathode over the right supraorbital region, plus non-targeted fine motor training. Active stimulation will be delivered at 1 milliampere for 20 minutes during the first part of each session, three times per week for 20 sessions over about 7 weeks. Non-targeted fine motor training will be the same as Intervention group 2. Intervention 7: Intervention group 6: active dual-site transcranial direct current stimulation with a two-channel montage, including one channel over the temporoparietal junction and one channel over the left primary motor cortex, plus the integrated phonological and fine motor intervention. Each channel will deliver 1 milliampere for 20 minutes during the first part of each session, three times per week for 20 sessions over about 7 weeks. The integrated intervention will be the same as Intervention group 3. Intervention 8: Intervention group 7: active transcranial direct current stimulation with the anode over the left primary motor cortex and the cathode over the right supraorbital region, without any cognitive intervention. Active stimulation will be delivered at 1 milliampere for 20 minutes per session, three times per week for 20 sessions over about 7 weeks. Participants will watch a silent nature documentary during the session to control for time and attention. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to confidentiality and ethical considerations related to minor participants, deidentified individual participant data will not be shared.
public Mohammad Amin Javedanfar
Institute for Cognitive and Brain Sciences, Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2990 2761 m_javedanfar@sbu.ac.ir Shahid Beheshti University scientific Shahriar Gharibzadeh
Institute for Cognitive and Brain Sciences, Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2990 2761 s_gharibzade@sbu.ac.ir Shahid Beheshti University Iran (Islamic Republic of) 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. 108 months 119 months Male 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). F81.0 Specific reading disorder Placebo Behavior Behavior Behavior Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Control group: Participants will receive usual school education plus sham transcranial direct current stimulation. The sham stimulation 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. For the control group, the sham montage will be randomly selected from the three main montages and will remain fixed across all 20 sessions. Sessions will be conducted three times per week for approximately seven weeks. Intervention group 1: sham transcranial direct current stimulation with the anode over the left temporoparietal junction and the cathode over the right temporoparietal junction, plus phonological awareness training. Sham stimulation will be applied for only 30 seconds. Phonological awareness training will be delivered in 20 sessions of 60 minutes each, three times per week for about 7 weeks, and will cover syllable segmentation, rhyme, phoneme blending and segmentation, initial and final phoneme identification, phoneme manipulation, and grapheme-to-phoneme mapping. Intervention group 2: sham transcranial direct current stimulation with the anode over the left primary motor cortex and the cathode over the right supraorbital region, plus non-targeted fine motor training. Sham stimulation will be applied for only 30 seconds. Non-targeted fine motor training will include activities without linguistic content, such as free play with dough, bead threading, pegboard tasks, and other manual dexterity exercises, delivered in 20 sessions of 60 minutes each, three times per week for about 7 weeks. Intervention group 3: sham transcranial direct current stimulation with a two-channel montage, including one channel over the temporoparietal junction and one channel over the left primary motor cortex, plus the integrated phonological and fine motor intervention. Sham stimulation will be applied for only 30 seconds on both channels. The integrated intervention will combine phonological awareness training with targeted fine motor activities linked to reading, such as forming letters with dough and stringing beads marked with phonemes, delivered in 20 sessions of 60 minutes each, three times per week for about 7 weeks. Intervention group 4: active transcranial direct current stimulation with the anode over the left temporoparietal junction and the cathode over the right temporoparietal junction, plus phonological awareness training. Active stimulation will be delivered at 1 milliampere for 20 minutes during the first part of each session, three times per week for 20 sessions over about 7 weeks. Phonological awareness training will be the same as Intervention group 1. Intervention group 5: active transcranial direct current stimulation with the anode over the left primary motor cortex and the cathode over the right supraorbital region, plus non-targeted fine motor training. Active stimulation will be delivered at 1 milliampere for 20 minutes during the first part of each session, three times per week for 20 sessions over about 7 weeks. Non-targeted fine motor training will be the same as Intervention group 2. Intervention group 6: active dual-site transcranial direct current stimulation with a two-channel montage, including one channel over the temporoparietal junction and one channel over the left primary motor cortex, plus the integrated phonological and fine motor intervention. Each channel will deliver 1 milliampere for 20 minutes during the first part of each session, three times per week for 20 sessions over about 7 weeks. The integrated intervention will be the same as Intervention group 3. Intervention group 7: active transcranial direct current stimulation with the anode over the left primary motor cortex and the cathode over the right supraorbital region, without any cognitive intervention. Active stimulation will be delivered at 1 milliampere for 20 minutes per session, three times per week for 20 sessions over about 7 weeks. Participants will watch a silent nature documentary during the session to control for time and attention. Composite score of Factor 1 of the Reading and Dyslexia Test, which includes word reading, phoneme deletion, nonword reading, and word comprehension subtests. Timepoint: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention. Method of measurement: Reading and Dyslexia Test (a standardized Persian test for reading and dyslexia). The composite score of Factor 1 is calculated from the word reading, phoneme deletion, nonword reading, and word comprehension subtests. Fine motor performance as measured by the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, manual dexterity and upper-limb coordination subtests. Timepoint: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention. Method of measurement: Bruininks-Oseretsky Test of Motor Proficiency, Second Edition. Raw scores of the common items in the manual dexterity and upper-limb coordination subtests will be used for longitudinal comparison. Rapid automatized naming speed, including naming of objects, colors, numbers, and letters. Timepoint: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention. Method of measurement: Rapid Automatized Naming Test. The total time in seconds to name each card is recorded for the four subtests: objects, colors, numbers, and letters. Text reading fluency defined as the number of correct words read per minute on a grade-level reading passage. Timepoint: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention. Method of measurement: Reading aloud a 100-word passage selected from the third-grade Persian textbook. 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. Shahid Beheshti University Approved 2024-07-06 Research Ethics Committees of Shahid Beheshti University Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)