Consultation, Psychological, Research and Specialized Services Center of Isfahan Province General Department of Education
Isfahan, 8155113853, Iran
Location contact
Mohammad Amin Javedanfar, MSc
CONTACT
Mohammad Amin Javedanfar, MSc
SUB_INVESTIGATOR
NCT Number: NCT07781761
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.
Trial opening soon.
Get Notified108 month–119 month
Male
Interventional
Not applicable
Isfahan, 8155113853, Iran
Mohammad Amin Javedanfar, MSc
CONTACT
Mohammad Amin Javedanfar, MSc
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: 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.
Other names: Sham tDCS
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: PA 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: Fine motor training
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: Combined intervention
Participants receive the standard school curriculum without additional cognitive or motor training.
Time frame: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
Composite score of Factor 1 of the Reading and Dyslexia Test, which includes word reading, phoneme deletion, nonword reading, and word comprehension subtests.
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.
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.
Time frame: Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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.
Contact information is provided by the study sponsor or research team.
Shahid Beheshti University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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