Trial Outcomes & Findings for Neural Mechanisms of Successful Intervention in Children With Dyslexia (NCT NCT04323488)
NCT ID: NCT04323488
Last Updated: 2025-11-14
Results Overview
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.
COMPLETED
NA
90 participants
Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up
2025-11-14
Participant Flow
Participant milestones
| Measure |
Lindamood-Bell Seeing Stars
Subjects receive reading instruction Lindamood-Bell Seeing Stars that focuses on systematic training in the building blocks of skilled reading.
|
Control
Subjects are followed longitudinally but do not receive intervention
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
46
|
|
Overall Study
Began study procedures
|
44
|
43
|
|
Overall Study
COMPLETED
|
40
|
37
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neural Mechanisms of Successful Intervention in Children With Dyslexia
Baseline characteristics by cohort
| Measure |
Lindamood-Bell Seeing Stars
n=44 Participants
Subjects receive reading instruction Lindamood-Bell Seeing Stars that focuses on systematic training in the building blocks of skilled reading.
|
Control
n=46 Participants
Subjects are followed longitudinally but do not receive intervention
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
44 Participants
n=171 Participants
|
46 Participants
n=23 Participants
|
90 Participants
n=306 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
|
Sex/Gender, Customized
Female
|
20 Participants
n=171 Participants
|
22 Participants
n=23 Participants
|
42 Participants
n=306 Participants
|
|
Sex/Gender, Customized
Male
|
23 Participants
n=171 Participants
|
24 Participants
n=23 Participants
|
47 Participants
n=306 Participants
|
|
Sex/Gender, Customized
Non-binary
|
1 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=306 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=171 Participants
|
9 Participants
n=23 Participants
|
21 Participants
n=306 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=171 Participants
|
32 Participants
n=23 Participants
|
64 Participants
n=306 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=171 Participants
|
5 Participants
n=23 Participants
|
5 Participants
n=306 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=306 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=171 Participants
|
7 Participants
n=23 Participants
|
10 Participants
n=306 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=306 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=171 Participants
|
2 Participants
n=23 Participants
|
6 Participants
n=306 Participants
|
|
Race/Ethnicity, Customized
White
|
28 Participants
n=171 Participants
|
24 Participants
n=23 Participants
|
52 Participants
n=306 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 Participants
n=171 Participants
|
4 Participants
n=23 Participants
|
6 Participants
n=306 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=171 Participants
|
4 Participants
n=23 Participants
|
8 Participants
n=306 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer
|
1 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=306 Participants
|
|
Race/Ethnicity, Customized
Not reported/unknown
|
0 Participants
n=171 Participants
|
5 Participants
n=23 Participants
|
5 Participants
n=306 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=171 Participants
|
43 Participants
n=23 Participants
|
87 Participants
n=306 Participants
|
PRIMARY outcome
Timeframe: Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow upPopulation: Participants with readable scans (i.e., low-movement, high quality) at the respective time point
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.
Outcome measures
| Measure |
Lindamood-Bell Seeing Stars
n=44 Participants
Subjects receive reading instruction Lindamood-Bell Seeing Stars that focuses on systematic training in the building blocks of skilled reading.
|
Control
n=37 Participants
Subjects are followed longitudinally but do not receive intervention
|
|---|---|---|
|
White Matter Plasticity - Left Arcuate Tract
baseline
|
0.837 mm^2/s
Standard Deviation 0.039
|
0.838 mm^2/s
Standard Deviation 0.033
|
|
White Matter Plasticity - Left Arcuate Tract
2 weeks post-intervention
|
0.842 mm^2/s
Standard Deviation 0.041
|
0.844 mm^2/s
Standard Deviation 0.038
|
|
White Matter Plasticity - Left Arcuate Tract
1 year follow-up
|
0.839 mm^2/s
Standard Deviation 0.038
|
0.830 mm^2/s
Standard Deviation 0.038
|
PRIMARY outcome
Timeframe: Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow upPopulation: Participants with readable scans (i.e., low-movement, high quality) at the respective time point
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.
Outcome measures
| Measure |
Lindamood-Bell Seeing Stars
n=44 Participants
Subjects receive reading instruction Lindamood-Bell Seeing Stars that focuses on systematic training in the building blocks of skilled reading.
|
Control
n=37 Participants
Subjects are followed longitudinally but do not receive intervention
|
|---|---|---|
|
White Matter Plasticity - Inferior Longitudinal Tract
baseline
|
0.963 mm^2/s
Standard Deviation 0.036
|
0.957 mm^2/s
Standard Deviation 0.028
|
|
White Matter Plasticity - Inferior Longitudinal Tract
2 weeks post-intervention
|
0.963 mm^2/s
Standard Deviation 0.034
|
0.956 mm^2/s
Standard Deviation 0.035
|
|
White Matter Plasticity - Inferior Longitudinal Tract
1 year follow-up
|
0.957 mm^2/s
Standard Deviation 0.040
|
0.952 mm^2/s
Standard Deviation 0.039
|
PRIMARY outcome
Timeframe: Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow upPopulation: Participants with readable scans (i.e., low-movement, high quality) at the respective time point
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.
Outcome measures
| Measure |
Lindamood-Bell Seeing Stars
n=42 Participants
Subjects receive reading instruction Lindamood-Bell Seeing Stars that focuses on systematic training in the building blocks of skilled reading.
|
Control
n=42 Participants
Subjects are followed longitudinally but do not receive intervention
|
|---|---|---|
|
Visual Word Form Area (VWFA) Size
baseline
|
142.00 vertices
Standard Deviation 178.71
|
302.74 vertices
Standard Deviation 385.92
|
|
Visual Word Form Area (VWFA) Size
2 weeks post-intervention
|
146.69 vertices
Standard Deviation 179.47
|
282.40 vertices
Standard Deviation 372.00
|
|
Visual Word Form Area (VWFA) Size
1 year follow-up
|
375.53 vertices
Standard Deviation 363.50
|
337.20 vertices
Standard Deviation 333.21
|
PRIMARY outcome
Timeframe: Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow upPopulation: Participants with available data at the respective time point
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
Outcome measures
| Measure |
Lindamood-Bell Seeing Stars
n=44 Participants
Subjects receive reading instruction Lindamood-Bell Seeing Stars that focuses on systematic training in the building blocks of skilled reading.
|
Control
n=43 Participants
Subjects are followed longitudinally but do not receive intervention
|
|---|---|---|
|
Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery
baseline
|
80.75 score on a scale
Standard Deviation 10.52
|
96.85 score on a scale
Standard Deviation 17.30
|
|
Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery
2 weeks post-intervention
|
88.33 score on a scale
Standard Deviation 9.90
|
96.02 score on a scale
Standard Deviation 19.20
|
|
Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery
1 year follow-up
|
89.95 score on a scale
Standard Deviation 8.50
|
95.10 score on a scale
Standard Deviation 16.97
|
Adverse Events
Lindamood-Bell Seeing Stars
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place