NCT04323488

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 14, 2025

Completed
Last Updated

November 14, 2025

Status Verified

October 1, 2025

Enrollment Period

3.3 years

First QC Date

March 23, 2020

Results QC Date

September 20, 2025

Last Update Submit

October 30, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up

  • 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.

    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) 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.

    Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up

  • 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

    Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up

Study Arms (2)

Lindamood-Bell Seeing Stars

EXPERIMENTAL

Subjects receive reading instruction focusing on the building blocks of reading

Behavioral: Lindamood-Bell Seeing Stars

Control

NO INTERVENTION

Subjects are followed longitudinally but do not receive intervention

Interventions

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.

Lindamood-Bell Seeing Stars

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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 Mar 24;45(19):e1767242025. doi: 10.1523/JNEUROSCI.1767-24.2025. Online ahead of print.

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Jason Yeatman, PhD
Organization
Stanford University

Study Officials

  • Jason D Yeatman, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: subjects are seen before and after receiving 8 weeks of reading instruction
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 26, 2020

Study Start

May 1, 2021

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

November 14, 2025

Results First Posted

November 14, 2025

Record last verified: 2025-10

Locations