Dyslexia, Developmental
Conditions
Brief summary
Dyslexia, an impairment in accurate or fluent word recognition, is the most common learning disability affecting roughly ten percent of children. This proposal capitalizes on cutting edge neuroimaging methods, in combination with reading education programs, to generate a new understanding of how successful reading education shapes the development of the brain circuits that support skilled reading. A deeper understanding of the mechanisms of successful remediation of dyslexia, and individual differences in learning, will pave the way for personalized approaches to dyslexia treatment.
Interventions
BEHAVIORALLindamood-Bell Seeing Stars
Seeing Stars in a curriculum developed by Lindamood-Bell. It is published and openly available. It involves systematic training in the building blocks of skilled reading.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
subjects are seen before and after receiving 8 weeks of reading instruction
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Reading difficulties defined as low scores on standardized measures of reading skills
Exclusion criteria
* no major contraindication for MRI (braces, metal implants, pacemakers, vascular stents, or metallic ear tubes). * Because the study involves measurements of reading and language ability, new recruits will be native English speakers. * Subjects have no history of neurological disorder, significant psychiatric problems * exclude claustrophobic subjects since an MRI might be uncomfortable for them.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| White Matter Plasticity - Left Arcuate Tract | Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up | Change in white matter mean diffusivity (MD) measured with diffusion MRI. MD quantifies the average magnitude of water diffusion within a given region of tissue. An increase in mean diffusivity (MD) suggests an increase in free water movement (corresponds to less white matter integrity), while a decrease in MD suggests restricted water diffusion, potentially from increased cellular density (corresponds to greater white matter integrity). Values typically range from approximately 0.5 to 1.5 × 10\^-3 mm²/s in healthy white matter. |
| White Matter Plasticity - Inferior Longitudinal Tract | Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up | Change in white matter mean diffusivity (MD) measured with diffusion MRI. MD quantifies the average magnitude of water diffusion within a given region of tissue. An increase in mean diffusivity (MD) suggests an increase in free water movement (corresponds to less white matter integrity), while a decrease in MD suggests restricted water diffusion, potentially from increased cellular density (corresponds to greater white matter integrity). Values typically range from approximately 0.5 to 1.5 × 10\^-3 mm²/s in healthy white matter. |
| Visual Word Form Area (VWFA) Size | Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up | Visual Word Form Area (VWFA) refers to a region in the brain associated with the recognition of written words. VWFA size is calculated as the number of vertices in the cotrical surface. There are no definitive clinical relevant thresholds for the size of the VWFA that apply universally. Research indicates that variations in VWFA size and activation are associated with reading abilities and disorders. |
| Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery | Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up | The Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery results in a composite score across multiple assessments. Assessment scores are transformed to create an overall score range of 0 to 200. A score of 100 indicates average reading ability. Scores below 85 may indicate potential reading difficulties |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lindamood-Bell Seeing Stars Subjects receive reading instruction Lindamood-Bell Seeing Stars that focuses on systematic training in the building blocks of skilled reading. | 44 |
| Control Subjects are followed longitudinally but do not receive intervention | 46 |
| Total | 90 |
Baseline characteristics
| Characteristic | Lindamood-Bell Seeing Stars | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 44 Participants | 46 Participants | 90 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 9 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 32 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 5 Participants | 5 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 7 Participants | 10 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized More than one race | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not reported/unknown | 0 Participants | 5 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 4 Participants | 8 Participants |
| Race/Ethnicity, Customized Prefer not to answer | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 28 Participants | 24 Participants | 52 Participants |
| Region of Enrollment United States | 44 Participants | 43 Participants | 87 Participants |
| Sex/Gender, Customized Female | 20 Participants | 22 Participants | 42 Participants |
| Sex/Gender, Customized Male | 23 Participants | 24 Participants | 47 Participants |
| Sex/Gender, Customized Non-binary | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 43 |
| other Total, other adverse events | 0 / 44 | 0 / 43 |
| serious Total, serious adverse events | 0 / 44 | 0 / 43 |
Outcome results
Primary
Visual Word Form Area (VWFA) Size
Visual Word Form Area (VWFA) refers to a region in the brain associated with the recognition of written words. VWFA size is calculated as the number of vertices in the cotrical surface. There are no definitive clinical relevant thresholds for the size of the VWFA that apply universally. Research indicates that variations in VWFA size and activation are associated with reading abilities and disorders.
Time frame: Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up
Population: Participants with readable scans (i.e., low-movement, high quality) at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lindamood-Bell Seeing Stars | Visual Word Form Area (VWFA) Size | baseline | 142.00 vertices | Standard Deviation 178.71 |
| Lindamood-Bell Seeing Stars | Visual Word Form Area (VWFA) Size | 2 weeks post-intervention | 146.69 vertices | Standard Deviation 179.47 |
| Lindamood-Bell Seeing Stars | Visual Word Form Area (VWFA) Size | 1 year follow-up | 375.53 vertices | Standard Deviation 363.5 |
| Control | Visual Word Form Area (VWFA) Size | baseline | 302.74 vertices | Standard Deviation 385.92 |
| Control | Visual Word Form Area (VWFA) Size | 2 weeks post-intervention | 282.40 vertices | Standard Deviation 372 |
| Control | Visual Word Form Area (VWFA) Size | 1 year follow-up | 337.20 vertices | Standard Deviation 333.21 |
Comparison: Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)p-value: 0.6t-test, 2 sided
Comparison: Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)p-value: 0.03t-test, 2 sided
Comparison: Within-group analysis of change from baseline and 1 year follow upp-value: 0.6t-test, 2 sided
Comparison: Within-group analysis of change from baseline and 1 year follow upp-value: 0.03t-test, 2 sided
Primary
White Matter Plasticity - Inferior Longitudinal Tract
Change in white matter mean diffusivity (MD) measured with diffusion MRI. MD quantifies the average magnitude of water diffusion within a given region of tissue. An increase in mean diffusivity (MD) suggests an increase in free water movement (corresponds to less white matter integrity), while a decrease in MD suggests restricted water diffusion, potentially from increased cellular density (corresponds to greater white matter integrity). Values typically range from approximately 0.5 to 1.5 × 10\^-3 mm²/s in healthy white matter.
Time frame: Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up
Population: Participants with readable scans (i.e., low-movement, high quality) at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lindamood-Bell Seeing Stars | White Matter Plasticity - Inferior Longitudinal Tract | baseline | 0.963 mm^2/s | Standard Deviation 0.036 |
| Lindamood-Bell Seeing Stars | White Matter Plasticity - Inferior Longitudinal Tract | 2 weeks post-intervention | 0.963 mm^2/s | Standard Deviation 0.034 |
| Lindamood-Bell Seeing Stars | White Matter Plasticity - Inferior Longitudinal Tract | 1 year follow-up | 0.957 mm^2/s | Standard Deviation 0.04 |
| Control | White Matter Plasticity - Inferior Longitudinal Tract | baseline | 0.957 mm^2/s | Standard Deviation 0.028 |
| Control | White Matter Plasticity - Inferior Longitudinal Tract | 2 weeks post-intervention | 0.956 mm^2/s | Standard Deviation 0.035 |
| Control | White Matter Plasticity - Inferior Longitudinal Tract | 1 year follow-up | 0.952 mm^2/s | Standard Deviation 0.039 |
Comparison: Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)p-value: 0.524t-test, 2 sided
Comparison: Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)p-value: 0.379t-test, 2 sided
Comparison: Within-group analysis of change from baseline and 1 year follow upp-value: 0.01t-test, 2 sided
Comparison: Within-group analysis of change from baseline and 1 year follow upp-value: 0.017t-test, 2 sided
Primary
White Matter Plasticity - Left Arcuate Tract
Change in white matter mean diffusivity (MD) measured with diffusion MRI. MD quantifies the average magnitude of water diffusion within a given region of tissue. An increase in mean diffusivity (MD) suggests an increase in free water movement (corresponds to less white matter integrity), while a decrease in MD suggests restricted water diffusion, potentially from increased cellular density (corresponds to greater white matter integrity). Values typically range from approximately 0.5 to 1.5 × 10\^-3 mm²/s in healthy white matter.
Time frame: Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up
Population: Participants with readable scans (i.e., low-movement, high quality) at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lindamood-Bell Seeing Stars | White Matter Plasticity - Left Arcuate Tract | baseline | 0.837 mm^2/s | Standard Deviation 0.039 |
| Lindamood-Bell Seeing Stars | White Matter Plasticity - Left Arcuate Tract | 2 weeks post-intervention | 0.842 mm^2/s | Standard Deviation 0.041 |
| Lindamood-Bell Seeing Stars | White Matter Plasticity - Left Arcuate Tract | 1 year follow-up | 0.839 mm^2/s | Standard Deviation 0.038 |
| Control | White Matter Plasticity - Left Arcuate Tract | baseline | 0.838 mm^2/s | Standard Deviation 0.033 |
| Control | White Matter Plasticity - Left Arcuate Tract | 2 weeks post-intervention | 0.844 mm^2/s | Standard Deviation 0.038 |
| Control | White Matter Plasticity - Left Arcuate Tract | 1 year follow-up | 0.830 mm^2/s | Standard Deviation 0.038 |
Comparison: Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)p-value: 0.925t-test, 2 sided
Comparison: Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)p-value: 0.834t-test, 2 sided
Comparison: Within-group analysis of change from baseline and 1 year follow upp-value: 0.18t-test, 2 sided
Comparison: Within-group analysis of change from baseline and 1 year follow upp-value: 0.091t-test, 2 sided
Primary
Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery
The Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery results in a composite score across multiple assessments. Assessment scores are transformed to create an overall score range of 0 to 200. A score of 100 indicates average reading ability. Scores below 85 may indicate potential reading difficulties
Time frame: Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lindamood-Bell Seeing Stars | Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery | baseline | 80.75 score on a scale | Standard Deviation 10.52 |
| Lindamood-Bell Seeing Stars | Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery | 2 weeks post-intervention | 88.33 score on a scale | Standard Deviation 9.9 |
| Lindamood-Bell Seeing Stars | Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery | 1 year follow-up | 89.95 score on a scale | Standard Deviation 8.5 |
| Control | Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery | baseline | 96.85 score on a scale | Standard Deviation 17.3 |
| Control | Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery | 2 weeks post-intervention | 96.02 score on a scale | Standard Deviation 19.2 |
| Control | Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery | 1 year follow-up | 95.10 score on a scale | Standard Deviation 16.97 |
Comparison: Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)p-value: <0.001t-test, 2 sided
Comparison: Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)p-value: 0.29t-test, 2 sided
Comparison: Within-group analysis of change from baseline and 1 year follow upp-value: <0.001t-test, 2 sided
Comparison: Within-group analysis of change from baseline and 1 year follow upp-value: 0.26t-test, 2 sided