About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Active transcranial direct current stimulation (tDCS)
DeviceActive 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)
DeviceSham 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 training
Behavioral20 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 training
Behavioral20 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 intervention
Behavioral20 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 education
Other interventionParticipants receive the standard school curriculum without additional cognitive or motor training.
Treatment groups
8
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
Sponsors and contacts
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