Back to resultsRestoring Neural Oscillatory Communication in Developmental Dyslexia
Primary Purpose
Developmental Dyslexia
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Parietal tACS combined with visuo-attentional training
Sham (placebo) tACS combined with visuo-attentional training
Sham (placebo) tACS combined with phonics training
Sponsored by
About this trial
This is an interventional basic science trial for Developmental Dyslexia
Eligibility Criteria
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)
Sites / Locations
- Luca RonconiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Group DD1
Group DD2
Group DD3
Arm Description
tACS + visuo-attentional training
Sham (placebo) tACS + visuo-attentional training
Sham (placebo) tACS + phonics training
Outcomes
Primary Outcome Measures
Reading score
Text, word and pseudowords reading score
Secondary Outcome Measures
Full Information
NCT ID
NCT05583136
First Posted
October 7, 2022
Last Updated
October 13, 2022
Sponsor
Università Vita-Salute San Raffaele
1. Study Identification
Unique Protocol Identification Number
NCT05583136
Brief Title
Restoring Neural Oscillatory Communication in Developmental Dyslexia
Official Title
Restoring Neural Oscillatory Communication Between Dorsal and Ventral Visual Streams in Developmental Dyslexia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 14, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università Vita-Salute San Raffaele
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Dyslexia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group DD1
Arm Type
Experimental
Arm Description
tACS + visuo-attentional training
Arm Title
Group DD2
Arm Type
Active Comparator
Arm Description
Sham (placebo) tACS + visuo-attentional training
Arm Title
Group DD3
Arm Type
Active Comparator
Arm Description
Sham (placebo) tACS + phonics training
Intervention Type
Device
Intervention Name(s)
Parietal tACS combined with visuo-attentional training
Intervention Description
Parietal tACS combined with visuo-attentional training
Intervention Type
Device
Intervention Name(s)
Sham (placebo) tACS combined with visuo-attentional training
Intervention Description
Sham (placebo) tACS combined with visuo-attentional training
Intervention Type
Device
Intervention Name(s)
Sham (placebo) tACS combined with phonics training
Intervention Description
Sham (placebo) tACS combined with phonics training
Primary Outcome Measure Information:
Title
Reading score
Description
Text, word and pseudowords reading score
Time Frame
Pre-training, 1-7 days post-training, follow-up at 1 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Ronconi, PhD
Phone
0226434887
Email
ronconi.luca@unisr.it
Facility Information:
Facility Name
Luca Ronconi
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Ronconi, PhD
Phone
0226434887
Email
ronconi.luca@unisr.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Restoring Neural Oscillatory Communication in Developmental Dyslexia
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