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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Mohammad Amin Javedanfar, MSc
- 전화번호: +98 21 2990 2761
- 이메일: m_javedanfar@sbu.ac.ir
연구 장소
-
-
Isfahan
-
Isfahan, Isfahan, 이란, 8155113853
- Consultation, Psychological, Research and Specialized Services Center of Isfahan Province General Department of Education
-
연락하다:
- Mohammad Amin Javedanfar, MSc
- 전화번호: +98 31 3265 5530
- 이메일: m_javedanfar@sbu.ac.ir
-
부수사관:
- Mohammad Amin Javedanfar, MSc
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
가짜 비교기: Control (Sham + Usual School)
Sham tDCS randomly selected montage + usual school education, no cognitive training
|
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.
다른 이름들:
Participants receive the standard school curriculum without additional cognitive or motor training.
|
|
가짜 비교기: Sham-PA
Sham tDCS TPJ + phonological awareness training
|
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.
다른 이름들:
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.
다른 이름들:
|
|
가짜 비교기: Sham-Motor
Sham tDCS M1 + non-targeted fine motor training
|
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.
다른 이름들:
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.
다른 이름들:
|
|
가짜 비교기: Sham-Comb
Sham dual-channel TPJ+M1 + combined phonological and fine motor intervention
|
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.
다른 이름들:
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.
다른 이름들:
|
|
실험적: Active-PA
Active tDCS TPJ + 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.
다른 이름들:
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.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
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.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
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.
다른 이름들:
|
|
실험적: Active-Only
Active tDCS M1 alone, no cognitive intervention
|
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Composite score of Factor 1 of the Reading and Dyslexia Test (NAMA)
기간: 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.
|
Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fine motor performance (BOT-2 manual dexterity and upper-limb coordination)
기간: 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.
|
Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
|
|
Rapid automatized naming speed
기간: 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.
|
Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
|
|
Text reading fluency (correct words per minute)
기간: 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.
|
Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
|
공동 작업자 및 조사자
수사관
- 연구 의자: Shahriar Gharibzadeh, Ph.D., Institute for Cognitive and Brain Sciences, Shahid Beheshti University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SBU-tDCS-Dyslexia-001
- IRCT20260817070696N1 (레지스트리 식별자: Iranian Registry of Clinical Trials)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .