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Clinical Trials/NCT04323488
NCT04323488
Completed
Not Applicable

Neural Mechanisms of Successful Intervention in Children With Dyslexia

Stanford University1 site in 1 country90 target enrollmentMay 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dyslexia, Developmental
Sponsor
Stanford University
Enrollment
90
Locations
1
Primary Endpoint
White Matter Plasticity - Left Arcuate Tract
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
September 1, 2024
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jason Yeatman

Assistant Professor

Stanford University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

White Matter Plasticity - Left Arcuate Tract

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

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

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

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

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

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

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

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

Study Sites (1)

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