Developmental DyslexiaLEXINCT02217696
Prediction and Intervention in Developmental Dyslexia
A study testing Computerized reading training in people with Developmental Dyslexia, run by University of Zurich at 1 site in Switzerland.
Trial summary
The long-term goal of this study is to improve prediction of poor reading outcome at preschool age by using a combination of behavioural and neuroimaging measures and to evaluate a specific computerized training program to support children with problems during reading acquisition. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Dyslexia
- What is being tested?
- Computerized reading training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2013to Jul 2018
- 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, native (CH-) German speaking subjects, with an estimated non-verbal intelligence quotient (IQ) >=80, without neurological and/or psychiatric disorder (except for attention deficit hyperactivity disorder, specific learning disorders, developmental language impairments)
- Additional criteria for subgroups:
- Recruitment of preschoolers (aged 5.5-7.5 years):
- Healthy children with increased risk for developmental dyslexia in their second year at kindergarten
- Recruitment of children in first grade (aged 6.5-8.5years):
- Children showing impairments in learning to read (first/second grade).
- Adults (aged 20-40 years):
- Healthy, normal reading
Who cannot join
- MRI contraindications
- No history of premature delivery and/or maternal reports of severe prenatal, perinatal or postnatal complications.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Clinics for Child and Adolescent Psychiatry, University of Zurich
Zurich, 8032
Silvia Brem, PhD
About this study
Official title: Neuronal Markers of Grapheme-phoneme Training Response for Prediction of Successful Reading Acquisition in Children at Familial Risk for Developmental Dyslexia
The long-term goal of this study is to improve prediction of poor reading outcome at preschool age by using a combination of behavioural and neuroimaging measures and to evaluate a specific computerized training program to support children with problems during reading acquisition.
- Conditions
- Developmental Dyslexia
- Being tested
- Computerized reading training
- Keywords
- Electroencephalography (EEG), Magnetic Resonance Imaging (MRI), Multimodal Neuroimaging, Development, Prediction, Intervention
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized reading trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Computerized reading training first | Experimental | Cross-over design: group first receives the intervention Receives: Other: Computerized reading training |
| Waiting Control First | Experimental | Cross-over design: group first serves as waiting control Receives: Other: Computerized reading training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in reading and spelling performance
Performance in normed reading and/or spelling (standardized tests) as a result of reading acquisition and training
Measured: Participants will be tested at three times for the duration of the cross-sectional intervention, an expected average of 8 months
Secondary outcomes (2)
Developmental and training induced changes in functional brain activation and brain structure
Changes in activation/structure of core language network regions assessed by EEG and MRI during development, learning and training
Measured: Participants will be tested after an expected average of 8, 12 and 16 months
Accuracy of prediction on reading performance outcome
Accuracy of prediction on reading performance (standardized tests) using behavioural and/or neuroimaging measures.
Neuroimaging measures: EEG and MRI (functional activation, structural measures from white and/or grey matter, temporal information from event-related potential and/or frequency analyses)
Measured: Participants will be tested at T1 and on average 8 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJul 2013
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Brem, PhD, Principal investigator, University Clinics for Child and Adolescent Psychiatry, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217696
- Sponsor's protocol ID
- LEXI SNF32003B_141201/1
- Other IDs
- 32003B_141201/1
- Acronym
- LEXI
- Status last verified
- Aug 2014
- First submitted
- 8 Aug 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronal Markers of Grapheme-phoneme Training Response for Prediction of Successful Reading Acquisition in Children at Familial Risk for Developmental Dyslexia
- ClinicalTrials.gov ID
- NCT02217696
- Acronym / sponsor ID
- LEXI / LEXI SNF32003B_141201/1
- Conditions
- Developmental Dyslexia
- Keywords
- Electroencephalography (EEG), Magnetic Resonance Imaging (MRI), Multimodal Neuroimaging, Development, Prediction, Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 15 Aug 2014 (estimated)
- 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 long-term goal of this study is to improve prediction of poor reading outcome at preschool age by using a combination of behavioural and neuroimaging measures and to evaluate a specific computerized training program to support children with problems during reading acquisition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized reading training first | Experimental | Other: Computerized reading trainingCross-over design: group first receives the intervention |
| Waiting Control First | Experimental | Other: Computerized reading trainingCross-over design: group first serves as waiting control |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Healthy, native (CH-) German speaking subjects, with an estimated non-verbal intelligence quotient (IQ) >=80, without neurological and/or psychiatric disorder (except for attention deficit hyperactivity disorder, specific learning disorders, developmental language impairments)
- Additional criteria for subgroups:
- Recruitment of preschoolers (aged 5.5-7.5 years):
- Healthy children with increased risk for developmental dyslexia in their second year at kindergarten
- Recruitment of children in first grade (aged 6.5-8.5years):
Key exclusion criteria (2 listed)
- MRI contraindications
- No history of premature delivery and/or maternal reports of severe prenatal, perinatal or postnatal complications.
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 |
|---|---|---|
| Computerized reading training | Other | Computerized reading training first, Waiting Control First |
Primary outcome
Changes in reading and spelling performance
Time frame: Participants will be tested at three times for the duration of the cross-sectional intervention, an expected average of 8 months
Performance in normed reading and/or spelling (standardized tests) as a result of reading acquisition and training
2 secondary outcomes
Developmental and training induced changes in functional brain activation and brain structure
Time frame: Participants will be tested after an expected average of 8, 12 and 16 months
Accuracy of prediction on reading performance outcome
Time frame: Participants will be tested at T1 and on average 8 months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
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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.
Silvia Brem, PhD principal investigator
University Clinics for Child and Adolescent Psychiatry, University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized reading training in people with Developmental Dyslexia, run by University of Zurich at 1 site in Switzerland.
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 8 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: status not confirmed, as of the sponsor's last update on 15 Aug 2014. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Brem, PhD (+41 43 499 2760, sbrem@kjpd.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in reading and spelling performance (time frame: Participants will be tested at three times for the duration of the cross-sectional intervention, an expected average of 8 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 15 Aug 2014.