Restoring Neural Oscillatory Communication in Developmental Dyslexia

Sponsor

Università Vita-Salute San Raffaele (Other)

Overall Status

Recruiting

CT.gov ID

NCT05583136

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Developmental Dyslexia	Device: Parietal tACS combined with visuo-attentional training Device: Sham (placebo) tACS combined with visuo-attentional training Device: Sham (placebo) tACS combined with phonics training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Dec 14, 2021

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Dec 14, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group DD1 tACS + visuo-attentional training	Device: Parietal tACS combined with visuo-attentional training 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 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 Sham (placebo) tACS combined with phonics training

Arm

Intervention/Treatment

Experimental: Group DD1

tACS + visuo-attentional training

Device: Parietal tACS combined with visuo-attentional training

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

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

Sham (placebo) tACS combined with phonics training

Outcome Measures

Primary Outcome Measures

Reading score [Pre-training, 1-7 days post-training, follow-up at 1 and 6 months]
Text, word and pseudowords reading score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

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:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Luca Ronconi	Milan		Italy	20132

Sponsors and Collaborators

Università Vita-Salute San Raffaele

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luca Ronconi, Professor, Università Vita-Salute San Raffaele

ClinicalTrials.gov Identifier:

NCT05583136

Other Study ID Numbers:

NeOsReDy-01

First Posted:

Oct 17, 2022

Last Update Posted:

Oct 17, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dyslexia

Study Results

No Results Posted as of Oct 17, 2022