ClinicalTrials.gg
CompletedNCT04323488Updated Nov 14, 2025Results posted

Neural Mechanisms of Successful Intervention in Children With Dyslexia

An interventional study of Lindamood-Bell Seeing Stars in Dyslexia, Developmental, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-14.

Sponsored by Stanford University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
8 Years to 12 Years
Sex
All
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Study 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.

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Conditions studied

  • Dyslexia, Developmental

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03

In context

Dyslexia

127 studies on the registry are indexed under Dyslexia; 27 are open to participants now.

This study's enrollment of 90 is above the median of 71 across 106 interventional studies indexed under Dyslexia.

Browse Dyslexia studies →

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Reading difficulties defined as low scores on standardized measures of reading skills

Exclusion criteria

Exclusion Criteria:

  • no major 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Lindamood-Bell Seeing Stars

    Subjects receive reading instruction focusing on the building blocks of reading

    Behavioral: Lindamood-Bell Seeing Stars

  • No intervention
    Control

    Subjects are followed longitudinally but do not receive intervention

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.

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What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Results

Posted Nov 14, 2025

Participant flow

Participant flow — Overall Study
MilestoneLindamood-Bell Seeing StarsControl
Started4446
Began study procedures4443
Completed4037
Not completed49

Outcome measures

PrimaryWhite 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
Reported as:
Mean · mm^2/s
White Matter Plasticity - Left Arcuate Tract
mm^2/sLindamood-Bell Seeing StarsControl
baseline0.837 ± 0.0390.838 ± 0.033
2 weeks post-intervention0.842 ± 0.0410.844 ± 0.038
1 year follow-up0.839 ± 0.0380.830 ± 0.038
Statistical analysis
  • Lindamood-Bell Seeing Stars · t-test, 2 sided · p = 0.925 (The a priori threshold for statistical significance was \< 0.05.)
  • Control · t-test, 2 sided · p = 0.834 (The a priori threshold for statistical significance was \< 0.05.)
  • Lindamood-Bell Seeing Stars · t-test, 2 sided · p = 0.180 (The a priori threshold for statistical significance was \< 0.05.)
  • Control · t-test, 2 sided · p = 0.091 (The a priori threshold for statistical significance was \< 0.05.)
PrimaryWhite 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
Reported as:
Mean · mm^2/s
White Matter Plasticity - Inferior Longitudinal Tract
mm^2/sLindamood-Bell Seeing StarsControl
baseline0.963 ± 0.0360.957 ± 0.028
2 weeks post-intervention0.963 ± 0.0340.956 ± 0.035
1 year follow-up0.957 ± 0.0400.952 ± 0.039
Statistical analysis
  • Lindamood-Bell Seeing Stars · t-test, 2 sided · p = 0.524 (The a priori threshold for statistical significance was \< 0.05.)
  • Control · t-test, 2 sided · p = 0.379 (The a priori threshold for statistical significance was \< 0.05.)
  • Lindamood-Bell Seeing Stars · t-test, 2 sided · p = 0.010 (The a priori threshold for statistical significance was \< 0.05.)
  • Control · t-test, 2 sided · p = 0.017 (The a priori threshold for statistical significance was \< 0.05.)
PrimaryVisual 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
Reported as:
Mean · vertices
Visual Word Form Area (VWFA) Size
verticesLindamood-Bell Seeing StarsControl
baseline142.00 ± 178.71302.74 ± 385.92
2 weeks post-intervention146.69 ± 179.47282.40 ± 372.00
1 year follow-up375.53 ± 363.50337.20 ± 333.21
Statistical analysis
  • Lindamood-Bell Seeing Stars · t-test, 2 sided · p = 0.60 (The a priori threshold for statistical significance was \< 0.05.)
  • Control · t-test, 2 sided · p = 0.03 (The a priori threshold for statistical significance was \< 0.05.)
  • Lindamood-Bell Seeing Stars · t-test, 2 sided · p = 0.60
  • Control · t-test, 2 sided · p = 0.03 (The a priori threshold for statistical significance was \< 0.05.)
PrimaryWoodcock-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
Reported as:
Mean · score on a scale
Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery
score on a scaleLindamood-Bell Seeing StarsControl
baseline80.75 ± 10.5296.85 ± 17.30
2 weeks post-intervention88.33 ± 9.9096.02 ± 19.20
1 year follow-up89.95 ± 8.5095.10 ± 16.97
Statistical analysis
  • Lindamood-Bell Seeing Stars · t-test, 2 sided · p = < 0.001 (The a priori threshold for statistical significance was \< 0.05.)
  • Control · t-test, 2 sided · p = 0.29 (The a priori threshold for statistical significance was \< 0.05.)
  • Lindamood-Bell Seeing Stars · t-test, 2 sided · p = < 0.001 (The a priori threshold for statistical significance was \< 0.05.)
  • Control · t-test, 2 sided · p = 0.26 (The a priori threshold for statistical significance was \< 0.05.)

Adverse events

Collected over Up to 2.5 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lindamood-Bell Seeing Stars0/44 (0%)0/44 (0%)0/44 (0%)
Control0/43 (0%)0/43 (0%)0/43 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Lindamood-Bell Seeing StarsControlTotal
<=18 years444690
Between 18 and 65 years000
>=65 years000
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Lindamood-Bell Seeing StarsControlTotal
Female202242
Male232447
Non-binary101
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Lindamood-Bell Seeing StarsControlTotal
Hispanic or Latino12921
Not Hispanic or Latino323264
Unknown or Not Reported055
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Lindamood-Bell Seeing StarsControlTotal
American Indian or Alaska Native101
Asian3710
Native Hawaiian or Other Pacific Islander101
Black or African American426
White282452
More than one race246
Other448
Prefer not to answer101
Not reported/unknown055
Region of Enrollment
Region of Enrollment(Participants)Lindamood-Bell Seeing StarsControlTotal
United States444387
08

Study locations

1 site
  • Stanford University
    Stanford, California 94305, United States
09

References and documents

Publications

  • Stone HL, Mitchell JL, Fuentes-Jimenez M, Tran JE, Yeatman JD, Yablonski M. Anatomically Distinct Regions in the Inferior Frontal Cortex Are Modulated by Task and Reading Skill. J Neurosci. 2025 May 7;45(19):e1767242025. doi: 10.1523/JNEUROSCI.1767-24.2025. PubMed 40127940 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — All consent forms in the Yeatman lab contain a data sharing clause that allows de-identified data to be shared publicly. The lab policy is that data and analysis code are always publicly released to accompany each published manuscript from the lab. This policy ensures that published findings can be reproduced by other researchers and the general public. In our experience, this also creates a useful resource to document our methods, describe methodological decisions in greater detail than afforded by journal articles, and publicly release datasets that may be of utility to other researchers. Data and code are organized into a well-documented repository (see https://github.com/yeatmanlab) with a persistent digital identifier ensuring that it will be available in perpetuity. Within the repository is documentation to reproduce each manuscript figure and each reported statistic. The lab is a strong proponent of open science and has adhered to this lab policy for every published manuscript.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2021 to primary completion in Sep 2024, 40 months.

Results were first posted in Nov 2025, 1 year 2 months after primary completion.

Of 62 non-industry interventional studies with no phase under Dyslexia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 57. This study's 40 months is above that.

Counting every sponsor, half of 69 studies reached it within 24 months; a quarter within 9 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2020
First posted
Mar 26, 2020
StartActual
May 1, 2021
Primary completionActual
Sep 1, 2024
CompletionActual
Sep 1, 2024
Results first posted
Nov 14, 2025
Last update
Nov 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04323488
Responsible party
Jason Yeatman (Assistant Professor, Stanford University) — Principal investigator
First posted
Mar 26, 2020
Start date
May 1, 2021
Primary completion
Sep 1, 2024
Completion
Sep 1, 2024
Results posted
Nov 14, 2025
Last update
Nov 14, 2025

Study contacts

Jason D Yeatman, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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