Brain Stimulation With Combined Reading and Motor Training for Children With Dyslexia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age108-119
SponsorShahid Beheshti University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active transcranial direct current stimulation (tDCS)

    Device

    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.

  • Sham transcranial direct current stimulation (tDCS)

    Device

    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.

  • Phonological awareness training

    Behavioral

    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.

  • Non-targeted fine motor training

    Behavioral

    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.

  • Integrated phonological and fine motor intervention

    Behavioral

    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.

  • Usual school education

    Other intervention

    Participants receive the standard school curriculum without additional cognitive or motor training.

Treatment groups

160 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Control (Sham + Usual School)Sham comparator 2 interventions
Group B: Sham-PASham comparator 2 interventions
Group C: Sham-MotorSham comparator 2 interventions
Group D: Sham-CombSham comparator 2 interventions
Group E: Active-PAExperimental treatment 2 interventions
Group F: Active-MotorExperimental treatment 2 interventions
Group G: Active-CombExperimental treatment 2 interventions
Group H: Active-OnlyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.

Secondary outcomes

1

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.

Time frame
Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
2

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.

Time frame
Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.
3

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.

Time frame
Before intervention, immediately after the end of intervention, 3 months after intervention, and 6 months after intervention.

Other outcomes

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