[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653136":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":36,"studyPopulation":23,"armGroups":37,"interventions":78,"overallOfficials":115,"centralContacts":120,"locations":126,"responsibleParty":144,"collaborators":23,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":23,"eligibilityCriteria":154,"healthyVolunteers":150,"sex":155,"minAge":156,"maxAge":157,"enrollmentInfo":158,"targetDuration":23,"studyType":161,"phases":162,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":173,"whyStopped":23,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"fullName":5,"class":6},"Shahid Beheshti University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"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.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":23,"timePerspective":23,"maskingInfo":29},"RANDOMIZED","PARALLEL","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.","TREATMENT",{"masking":30,"maskingDescription":31,"whoMasked":32},"TRIPLE","Cognitive therapists are also blinded. The tDCS operator is the only unblinded person and has no role in cognitive training or outcome assessment. Data analysts are blinded until the primary analyses are completed. The Data Safety and Monitoring Board may be unblinded as needed for safety monitoring.",[33,34,35],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nThe tDCS protocol uses 1 mA current for 20 minutes per session over 20 sessions (3 sessions\u002Fweek). 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.\n\nPrimary 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.\n\nAssessments occur at baseline, immediately after the intervention, and at 3- and 6-month follow-ups.",[38,45,50,55,60,66,70,74],{"label":39,"type":40,"description":41,"interventionNames":42},"Control (Sham + Usual School)","SHAM_COMPARATOR","Sham tDCS randomly selected montage + usual school education, no cognitive training",[43,44],"Device: Sham transcranial direct current stimulation (tDCS)","Other: Usual school education",{"label":46,"type":40,"description":47,"interventionNames":48},"Sham-PA","Sham tDCS TPJ + phonological awareness training",[43,49],"Behavioral: Phonological awareness training",{"label":51,"type":40,"description":52,"interventionNames":53},"Sham-Motor","Sham tDCS M1 + non-targeted fine motor training",[43,54],"Behavioral: Non-targeted fine motor training",{"label":56,"type":40,"description":57,"interventionNames":58},"Sham-Comb","Sham dual-channel TPJ+M1 + combined phonological and fine motor intervention",[43,59],"Behavioral: Integrated phonological and fine motor intervention",{"label":61,"type":62,"description":63,"interventionNames":64},"Active-PA","EXPERIMENTAL","Active tDCS TPJ + phonological awareness training",[65,49],"Device: Active transcranial direct current stimulation (tDCS)",{"label":67,"type":62,"description":68,"interventionNames":69},"Active-Motor","Active tDCS M1 + non-targeted fine motor training",[65,54],{"label":71,"type":62,"description":72,"interventionNames":73},"Active-Comb","Active dual-site TPJ+M1 + combined phonological and fine motor intervention",[65,59],{"label":75,"type":62,"description":76,"interventionNames":77},"Active-Only","Active tDCS M1 alone, no cognitive intervention",[65],[79,86,92,99,105,111],{"type":80,"name":81,"description":82,"armGroupLabels":83,"otherNames":84},"DEVICE","Active transcranial direct current stimulation (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.",[71,67,75,61],[85],"tDCS",{"type":80,"name":87,"description":88,"armGroupLabels":89,"otherNames":90},"Sham transcranial direct current stimulation (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.",[39,56,51,46],[91],"Sham tDCS",{"type":93,"name":94,"description":95,"armGroupLabels":96,"otherNames":97},"BEHAVIORAL","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.",[61,46],[98],"PA training",{"type":93,"name":100,"description":101,"armGroupLabels":102,"otherNames":103},"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.",[67,51],[104],"Fine motor training",{"type":93,"name":106,"description":107,"armGroupLabels":108,"otherNames":109},"Integrated 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.",[71,56],[110],"Combined intervention",{"type":6,"name":112,"description":113,"armGroupLabels":114,"otherNames":23},"Usual school education","Participants receive the standard school curriculum without additional cognitive or motor training.",[39],[116],{"name":117,"affiliation":118,"role":119},"Shahriar Gharibzadeh, Ph.D.","Institute for Cognitive and Brain Sciences, Shahid Beheshti University","STUDY_CHAIR",[121],{"name":122,"role":123,"phone":124,"phoneExt":23,"email":125},"Mohammad Amin Javedanfar, MSc","CONTACT","+98 21 2990 2761","m_javedanfar@sbu.ac.ir",[127],{"facility":128,"status":23,"city":129,"state":129,"zip":130,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":138,"contacts":139},"Consultation, Psychological, Research and Specialized Services Center of Isfahan Province General Department of Education","Isfahan","8155113853","Iran","IR",{"type":134,"coordinates":135},"Point",[136,137],51.67462,32.65246,{"lat":137,"lon":136},[140,142],{"name":122,"role":123,"phone":141,"phoneExt":23,"email":125},"+98 31 3265 5530",{"name":122,"role":143,"phone":23,"phoneExt":23,"email":23},"SUB_INVESTIGATOR",{"type":145,"investigatorFullName":146,"investigatorTitle":147,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Mohammad Amin Javedanfar","Principal Investigator","100653136","brain-stimulation-with-combined-reading-and-motor-training-for-children-with-dyslexia-100653136",false,"NCT07781761","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","Inclusion Criteria:\n\n* 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.\n* Reading and Dyslexia Test (NAMA) T score ≤ 30 (at least 2 standard deviations below the mean).\n* Full Scale IQ ≥ 85 on the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V).\n* Score below 88 on the Spence Children's Anxiety Scale (SCAS).\n* 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.\n* Normal or corrected-to-normal vision and hearing.\n* No history of seizure or epilepsy, no scalp skin disease, no cochlear implant, cardiac pacemaker, or metal implants in the skull.\n* Written informed consent from parents or legal guardian and verbal assent from the child.\n\nExclusion Criteria:\n\n* Intellectual disability (Full Scale IQ \\\u003C 85).\n* Personal history of epilepsy or seizure disorder, or epilepsy in a first-degree relative.\n* Presence of cochlear implant, cardiac pacemaker, or metal implants in the skull.\n* Skin diseases or open lesions on the scalp at electrode sites.\n* Uncorrected visual or hearing impairments.\n* Other primary psychiatric or neurodevelopmental disorders requiring ongoing treatment (e.g., ADHD, autism spectrum disorder, severe anxiety disorder).","MALE","108 Months","119 Months",{"count":159,"type":160},160,"ESTIMATED","INTERVENTIONAL",[163],"NA","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.\n\nChildren 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).\n\nParticipants 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.\n\nReading 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.",[166],"Developmental Dyslexia",[166,85,168,169,170,171,172],"Phonological Awareness","Fine Motor Training","Reading","Children","Dual-site transcranial direct current stimulation","NOT_YET_RECRUITING","2026-08-21",{"date":176,"type":177},"2026-08-25","ACTUAL",{"date":179,"type":160},"2026-08-23",{"date":181,"type":160},"2027-08-01",{"name":5,"class":6},1]