Developmental DyslexiaNCT05583136
Restoring Neural Oscillatory Communication in Developmental Dyslexia
A study testing Parietal tACS combined with visuo-attentional training in people with Developmental Dyslexia, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Dyslexia
- What is being tested?
- Parietal tACS combined with visuo-attentional training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- 14 Dec 2021to 23 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patient (age between 18 and 35)
- Official Diagnosis of Developmental Dyslexia (DD)
- Normal or corrected-to-normal vision and hearing
- Normal motor skills
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restoring Neural Oscillatory Communication Between Dorsal and Ventral Visual Streams in Developmental Dyslexia
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.
- Conditions
- Developmental Dyslexia
- Being tested
- Parietal tACS combined with visuo-attentional training, Sham (placebo) tACS combined with visuo-attentional training, Sham (placebo) tACS combined with phonics training
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parietal tACS combined with visuo-attentional trainingDevice
Parietal tACS combined with visuo-attentional training
Sham (placebo) tACS combined with visuo-attentional trainingDevice
Sham (placebo) tACS combined with visuo-attentional training
Sham (placebo) tACS combined with phonics trainingDevice
Sham (placebo) tACS combined with phonics training
| Study group | Role | What they receive |
|---|---|---|
| Group DD1 | Experimental | tACS + visuo-attentional training Receives: Device: Parietal tACS combined with visuo-attentional training |
| Group DD2 | Active comparator | Sham (placebo) tACS + visuo-attentional training Receives: Device: Sham (placebo) tACS combined with visuo-attentional training |
| Group DD3 | Active comparator | Sham (placebo) tACS + phonics training Receives: Device: Sham (placebo) tACS combined with phonics training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading score
Text, word and pseudowords reading score
Measured: Pre-training, 1-7 days post-training, follow-up at 1 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start14 Dec 2021
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DyslexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Ronconi, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583136
- Sponsor's protocol ID
- NeOsReDy-01
- Status last verified
- Oct 2022
- First submitted
- 7 Oct 2022
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Neural Oscillatory Communication Between Dorsal and Ventral Visual Streams in Developmental Dyslexia
- ClinicalTrials.gov ID
- NCT05583136
- Acronym / sponsor ID
- NeOsReDy-01
- Conditions
- Developmental Dyslexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group DD1 | Experimental | Device: Parietal tACS combined with visuo-attentional trainingtACS + visuo-attentional training |
| Group DD2 | Active comparator | Device: Sham (placebo) tACS combined with visuo-attentional trainingSham (placebo) tACS + visuo-attentional training |
| Group DD3 | Active comparator | Device: Sham (placebo) tACS combined with phonics trainingSham (placebo) tACS + phonics training |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patient (age between 18 and 35)
- Official Diagnosis of Developmental Dyslexia (DD)
- Normal or corrected-to-normal vision and hearing
- Normal motor skills
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parietal tACS combined with visuo-attentional trainingParietal tACS combined with visuo-attentional training | Device | Group DD1 |
| Sham (placebo) tACS combined with visuo-attentional trainingSham (placebo) tACS combined with visuo-attentional training | Device | Group DD2 |
| Sham (placebo) tACS combined with phonics trainingSham (placebo) tACS combined with phonics training | Device | Group DD3 |
Primary outcome
Reading score
Time frame: Pre-training, 1-7 days post-training, follow-up at 1 and 6 months
Text, word and pseudowords reading score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parietal tACS combined with visuo-attentional training in people with Developmental Dyslexia, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading score (time frame: Pre-training, 1-7 days post-training, follow-up at 1 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.