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
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Mohammad Amin Javedanfar, MSc
- 電話番号：+98 21 2990 2761
- メール：m_javedanfar@sbu.ac.ir
研究場所
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Isfahan
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Isfahan、Isfahan、イラン、8155113853
- Consultation, Psychological, Research and Specialized Services Center of Isfahan Province General Department of Education
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コンタクト：
- Mohammad Amin Javedanfar, MSc
- 電話番号：+98 31 3265 5530
- メール：m_javedanfar@sbu.ac.ir
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副調査官：
- Mohammad Amin Javedanfar, MSc
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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偽コンパレータ：Control (Sham + Usual School)
Sham tDCS randomly selected montage + usual school education, no cognitive training
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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.
他の名前：
Participants receive the standard school curriculum without additional cognitive or motor training.
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偽コンパレータ：Sham-PA
Sham tDCS TPJ + phonological awareness training
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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.
他の名前：
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.
他の名前：
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偽コンパレータ：Sham-Motor
Sham tDCS M1 + non-targeted fine motor training
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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.
他の名前：
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.
他の名前：
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偽コンパレータ：Sham-Comb
Sham dual-channel TPJ+M1 + combined phonological and fine motor intervention
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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.
他の名前：
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.
他の名前：
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実験的：Active-PA
Active tDCS TPJ + phonological awareness training
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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.
他の名前：
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.
他の名前：
|
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実験的：Active-Motor
Active tDCS M1 + 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.
他の名前：
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.
他の名前：
|
|
実験的：Active-Comb
Active dual-site TPJ+M1 + combined 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.
他の名前：
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.
他の名前：
|
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実験的：Active-Only
Active tDCS M1 alone, no cognitive intervention
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Composite score of Factor 1 of the Reading and Dyslexia Test (NAMA)
時間枠：Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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Composite score of Factor 1 of the Reading and Dyslexia Test, which includes word reading, phoneme deletion, nonword reading, and word comprehension subtests.
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Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Fine motor performance (BOT-2 manual dexterity and upper-limb coordination)
時間枠：Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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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.
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Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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Rapid automatized naming speed
時間枠：Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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Rapid automatized naming speed, including naming of objects, colors, numbers, and letters.
The total time in seconds to name each card is recorded.
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Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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Text reading fluency (correct words per minute)
時間枠：Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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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.
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Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
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協力者と研究者
捜査官
- スタディチェア：Shahriar Gharibzadeh, Ph.D.、Institute for Cognitive and Brain Sciences, Shahid Beheshti University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SBU-tDCS-Dyslexia-001
- IRCT20260817070696N1 (レジストリ識別子：Iranian Registry of Clinical Trials)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
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