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.
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
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| Set for Variability | Experimental | Students 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 practices | Active comparator | The 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.
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)
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.
- First posted17 May 2022
- Study start1 Oct 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EEGStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armando Bertone, McGill University
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 20809790Hasko 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 25018723Tunmer 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 22293683Schulz 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
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Behavioural and Electrophysiological Effects of Reading Intervention in School-age Children With Dyslexia
- ClinicalTrials.gov ID
- NCT05376696
- Acronym / sponsor ID
- Intervention & EEG
- Conditions
- EEG
- Keywords
- EEG, N400, reading intervention, reading disability, pre-post
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 17 May 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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Set for Variability | Experimental | Behavioral: Set For VariabilityStudents 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" |
| Current best practices | Active comparator | Behavioral: Current Best PracticesThe 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 |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Have a diagnosis with Dyslexia from school psychologists, a psychiatrist
Key exclusion criteria (2 listed)
- Have a comorbid diagnosis with ADHD and Autism
- Have Epilespy
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 |
|---|---|---|
| Set For VariabilityThis intervention will focus on training students to use a sound variation of grapheme correspondence rule in order to read an irregular spelling word correctly. | Behavioural | Set for Variability |
| Current Best PracticesThis 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 | Behavioural | Current best practices |
Primary outcome
Physiological parameter using EEG
Time frame: 10 weeks after baseline
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.
1 secondary outcome
Standardized reading measures
Time frame: 10 weeks after baseline
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 21 May 2025.
- Background: PubMed 20809790Kutas 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.
- Background: PubMed 25018723Hasko 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.
- Background: PubMed 22293683Tunmer 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.
- Background: PubMed 18378166Schulz 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.
- Castle and Coltheart grapheme-phoneme reading testLink provided by the sponsor.
- Woodcock Johnson reading achievement testLink provided by the sponsor.
- WIAT reading comprehension testLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 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.