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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Composite score of Factor 1 of the Reading and Dyslexia Test (NAMA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 108 Months 至 119 Months（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Composite score of Factor 1 of the Reading and Dyslexia Test (NAMA)
时间窗: 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.
次要结局
- Fine motor performance (BOT-2 manual dexterity and upper-limb coordination)(Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.)
- Rapid automatized naming speed(Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.)
- Text reading fluency (correct words per minute)(Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.)
研究者
Mohammad Amin Javedanfar
Principal Investigator
Shahid Beheshti University