Restoring Neural Oscillatory Communication in Developmental Dyslexia

Developmental Dyslexia Clinical Trial

Official title:

Restoring Neural Oscillatory Communication Between Dorsal and Ventral Visual Streams in Developmental Dyslexia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05583136
• Other study ID #: NeOsReDy-01
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2021
• Est. completion date: December 14, 2024

Study information

• Verified date: October 2022
• Source: Università Vita-Salute San Raffaele
• Contact: Luca Ronconi, PhD
• Phone: 0226434887
• Email: ronconi.luca[@]unisr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 14, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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:

• 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)

Related Conditions & MeSH terms

• Developmental Dyslexia
• Dyslexia

Intervention

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

Locations

Country	Name	City	State
Italy	Luca Ronconi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reading score	Text, word and pseudowords reading score	Pre-training, 1-7 days post-training, follow-up at 1 and 6 months