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CompletedNCT05583136Updated Jan 27, 2025

Restoring Neural Oscillatory Communication in Developmental Dyslexia

An interventional study of Parietal tACS combined with visuo-attentional training and Sham (placebo) tACS combined with visuo-attentional training in Developmental Dyslexia, sponsored by IRCCS Ospedale San Raffaele. Completed at 1 site in Italy. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by IRCCS Ospedale San Raffaele · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
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Study summary

Developmental dyslexia (DD) is a multifactorial disorder that hampers the education of about 10% of individuals across cultures and is associated to both phonological and visual deficits. The latter have been linked to a deficit in the magnocellular-dorsal (M-D) visual stream, that has a critical role in guiding the activity of ventral visual stream areas where letters identity is extracted. Here, we will test the efficacy of transcranial alternate current stimulation (tACS) of the M-D stream combined with reading trainings in adult participants with DD, assessing the neurophysiological underpinnings of these new trainings with EEG and fMRI/DTI.

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Conditions studied

  • Developmental Dyslexia

Browse trials for

03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult patient (age between 18 and 35)
  • Official Diagnosis of Developmental Dyslexia (DD)
  • Normal or corrected-to-normal vision and hearing
  • Normal motor skills

Exclusion criteria

Exclusion Criteria:

  • Participants that cannot sign the consent form
  • Participants unable to read or understand and correctly complete the procedures foreseen by the study
  • Participants with a diagnosis or personal history of epilepsy or patients with a positive family history of epilepsy
  • Pregnant or breastfeeding patients
  • Participants with major psychiatric or neurological disorders and/or currently in psychopharmacological treatments.
  • Participants with metal implants in the brain, pacemakers, brain stimulators, cochlear implants.
  • Participants with claustrophobia (only for fMRI)
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    Group DD1

    tACS + visuo-attentional training

    Device: Parietal tACS combined with visuo-attentional training

  • Active comparator
    Group DD2

    Sham (placebo) tACS + visuo-attentional training

    Device: Sham (placebo) tACS combined with visuo-attentional training

  • Active comparator
    Group DD3

    Sham (placebo) tACS + phonics training

    Device: Sham (placebo) tACS combined with phonics training

Interventions

  • DeviceParietal tACS combined with visuo-attentional training

    Parietal tACS combined with visuo-attentional training

  • DeviceSham (placebo) tACS combined with visuo-attentional training

    Sham (placebo) tACS combined with visuo-attentional training

  • DeviceSham (placebo) tACS combined with phonics training

    Sham (placebo) tACS combined with phonics training

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What researchers measure

Primary outcomes

  1. Reading score

    Text, word and pseudowords reading score

    Time frame: Pre-training, 1-7 days post-training, follow-up at 1 and 6 months

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Study locations

1 site
  • Luca Ronconi
    Milan, 20132, Italy
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT05583136
Lead sponsor
IRCCS Ospedale San Raffaele
Responsible party
Luca Ronconi (Professor, IRCCS Ospedale San Raffaele) — Principal investigator
First posted
Oct 17, 2022
Start date
Dec 14, 2021
Primary completion
Dec 23, 2024
Completion
Dec 23, 2024
Last update
Jan 27, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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