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AzTrials

EEGNCT05376696

Behavioural and Physiological Measures of Young Students With Dyslexia

A study testing Set For Variability and Current Best Practices in people with EEG, run by McGill University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The proposed is reading intervention study to track neural changes in the brain. Students with dyslexia will participate in a reading study. Pre and post-analysis data will be obtained to see whether there will be positive neural and behavioural change. Read more about this study

Who is it for?
Ages 6 to 8 yearsHealthy volunteers can take part
Conditions the study is for
EEG
What is being tested?
Set For Variability and Current Best Practices
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
1 Oct 2022to 30 May 2023
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 6 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Have a diagnosis with Dyslexia from school psychologists, a psychiatrist

Who cannot join

  • Have a comorbid diagnosis with ADHD and Autism
  • Have Epilespy

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • McGill University

    Montreal, Quebec, H3A1Y2

Other trials in Canada

About this study

Official title: Assessing Behavioural and Electrophysiological Effects of Reading Intervention in School-age Children With Dyslexia

The proposed is reading intervention study to track neural changes in the brain. Students with dyslexia will participate in a reading study. Pre and post-analysis data will be obtained to see whether there will be positive neural and behavioural change.

Read the detailed description

A learning disability in reading is one of the most common neurobiological diagnoses in school-aged children. Statistics Canada reported that 3.2% of children in Canada have a learning disability (LD), making LD the most prevalent type of childhood condition. The new definition of LD has become more complicated to diagnose and treat children. Canadian universities invested recently in conducting research that tracks neural changes in the identification and remediation of LD. Electroencephalography (EEG) is one of the most common tools to inquire about brain information processing and neural changes. However, only one German study has used a reading intervention and EEG to track neural changes of children with LD in reading. This study delivered two reading interventions but did not report which intervention affected reading improvement. Hence, little is known about reading interventions that would induce positive neural changes in young children with LD. This proposal aims to implement a specific reading intervention in children and track neuronal changes. The results of this proposal will be invaluable in improving the predictive tools we use for early diagnosis of LD in reading, identifying better-targeted reading interventions, and in better allocation of resources to health and educational services.

To understand how the brain processes language in real-time, Event-Related Potential (ERPs) studies have been commonly used to assess the neural underpinnings of reading disability (RD), especially in children. Of particular interest, the N400 is a negative ERP waveform peaking at 400 milliseconds that is sensitive to the lexico-semantic aspect of language. The N400 represents an important language-relevant measure that can be used to investigate the neural basis of reading comprehension acquisition in typical readers, a process critical to reading development in school-age populations. The N400 assesses lexical-semantic processing when a student is introduced to a sentence with a pseudoword or a semantically incorrect word, as in "the pizza was too hot to cry." The N400 is sensitive in typical readers, indicating that they understand the semantic incongruity. There is also evidence that the N400 is atypical in individuals with reading disabilities and reading comprehension deficits.

These brain-based explanations give educational practice and understanding of the neural processes underlying reading difficulties, reading comprehension deficits, and potentially effective intervention mechanisms. Several studies demonstrate the potential relevance of neuroimaging for identifying a reading disability. Researchers have also shown that neural changes occur after a successful reading intervention. However, it remains unknown whether a reading intervention modulates reading-relevant brain activity, such as that of the N400.

One common approach to this problem is to teach common exception words by sight. An alternative approach some researchers have proposed is that in addition to teaching phonics, children are to be trained to "generate alternative pronunciations when they come to unknown words until they produce a pronunciation that is a real word, and which makes sense in context". This process is known as Set-for-Variability (SfV). For example, a child is taught the standard pronunciation of "ch" in the match, hatch, and catch. The child would then use this regularized pronunciation of "ch" to read the word stomach, an irregular spelled word. If a child fails to read the irregularly spelled word stomach using regularized pronunciation, then "the child has to change one or more sound associations and try again". Set-for-Variability is "the ability to determine the correct pronunciation of proximation to spoken English words". This means making a link from 'spelling pronunciations' (the product of synthetic phonics such as 'c'-'a'-'t' from the printed word 'cat') to a conventional pronunciation of that word. If pronouncing a word does not produce a meaningful phrase in context, the individual would need to try a different pronunciation.

The proposed study is a randomized-control study where thirty-eight students aged 6-7 years with a reading disability will be randomly assigned into a control and intervention group. The participants will be matched on age, IQ, and reading level before randomization. Participants in the control group will be included in a Current Best Practices (CBP) group and exposed to an intervention that focuses on grapheme-phoneme correspondence rules. In addition to the CBP, participants in the intervention group will receive 8-10 weeks of the Set-for-Variability intervention. Pre-post behavioural measures will be conducted to see if the Set-for-Variability intervention impacts word reading measured using validated assessment tools and the N400 amplitude. The present research will provide the first empirical data on the neural changes following a "Set-for-Variability"-based reading intervention.

Conditions
EEG
Being tested
Set For Variability, Current Best Practices
Keywords
EEG, N400, reading intervention, reading disability, pre-post
Medical subject headings
Dyslexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Set For VariabilityBehavioural

    This intervention will focus on training students to use a sound variation of grapheme correspondence rule in order to read an irregular spelling word correctly.

  • Current Best PracticesBehavioural

    This active control intervention will focus on training students to use grapheme-phoneme correspondence rules and sight words in the absence of set-for-variability component

Study groups in NCT05376696
Study groupRoleWhat they receive
Set for VariabilityExperimentalStudents in the experimental group will receive an average of 10-12 hrs. of small group intervention. All lessons will include (i) a focus on blending and segmenting phonemes within a synthetic phonics model, (ii) teaching common, vocabulary words (iii)shared book reading, and (iv) Set-for-variability component (SfV). This component will focus on teaching students how to find the sound variation of a grapheme-phoneme rule. For example when to use the sound /k/in /ch/ to read words such as "stomach"
Receives: Behavioral: Set For Variability
Current best practicesActive comparatorThe control group will receive current-best practices (CBP). The participants will receive a similar approach as in the intervention group without Set-for-Variability. The participants will receive (i) a focus on blending and segmenting phonemes within a synthetic phonics model, (ii) vocabulary, (iii) shared book reading, and (iv) the absence of teaching Set-for-Variability. Instead of Set-for-variability, the participants will receive sight word reading of frequent words. They will learn the most frequent pronunciation of vowels: ee, ea, oo, ou, oa, ai, ay
Receives: Behavioral: Current Best Practices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physiological parameter using EEG

    Time to detect the N400 after the onset of the target word at a window of 350-650 milliseconds. If the time of the N400 does not occur within this time frame window, this might indicate semantic integration deficits/and participant did not respond well to the intervention.

    Measured: 10 weeks after baseline

Secondary outcomes (1)
  1. Standardized reading measures

    Reading measures: Castle and Coltheart Word reading, Woodcock Johnson grapheme phoneme, WIAT reading comprehension and Set-for-Variability. [Percentile range]. Scores between 75-97 percentile are considered average to above average. Scores between 9-25 percentile are considered low and below average. Depending on where the participant scores will show improvement or no improvement to the intervention.

    Measured: 10 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2022
  2. Study start1 Oct 2022
  3. Primary completion30 May 2023
  4. Study completion30 May 2023

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
In this study, the students will be randomized to either the treatment group to receive the proposed intervention (Set for Variability) or the active control arm. This group will receive current best practices reading. After randomization, each participant will stay in their assigned treatment arm for ten weeks.
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05376696
Sponsor's protocol ID
Intervention & EEG
Status last verified
May 2025
First submitted
25 Apr 2022
Last updated
21 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kutas M, Federmeier KD. Thirty years and counting: finding meaning in the N400 component of the event-related brain potential (ERP). Annu Rev Psychol. 2011;62:621-47. doi: 10.1146/annurev.psych.093008.131123.

    PubMed 20809790
  • Hasko S, Groth K, Bruder J, Bartling J, Schulte-Korne G. What does the brain of children with developmental dyslexia tell us about reading improvement? ERP evidence from an intervention study. Front Hum Neurosci. 2014 Jun 26;8:441. doi: 10.3389/fnhum.2014.00441. eCollection 2014.

    PubMed 25018723
  • Tunmer WE, Chapman JW. The simple view of reading redux: vocabulary knowledge and the independent components hypothesis. J Learn Disabil. 2012 Sep-Oct;45(5):453-66. doi: 10.1177/0022219411432685. Epub 2012 Jan 31.

    PubMed 22293683
  • Schulz E, Maurer U, van der Mark S, Bucher K, Brem S, Martin E, Brandeis D. Impaired semantic processing during sentence reading in children with dyslexia: combined fMRI and ERP evidence. Neuroimage. 2008 May 15;41(1):153-68. doi: 10.1016/j.neuroimage.2008.02.012. Epub 2008 Mar 10.

    PubMed 18378166

Questions about this trial

What is this clinical trial studying?

A study testing Set For Variability and Current Best Practices in people with EEG, run by McGill University at 1 site in Canada.

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 1 inclusion and 2 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 21 May 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 Canada. 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?

Physiological parameter using EEG (time frame: 10 weeks after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05376696, which also lists 4 linked publications.

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 21 May 2025.

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