Neural Mechanisms of Successful Intervention in Children With Dyslexia

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Dyslexia, Developmental
• Intervention / Treatment: Behavioral: Lindamood-Bell Seeing Stars

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lindamood-Bell Seeing Stars; Subjects receive reading instruction focusing on the building blocks of reading	Behavioral: Lindamood-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.
No Intervention: Control; Subjects are followed longitudinally but do not receive intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
White matter plasticity	Change in white matter mean diffusivity measured with diffusion MRI	Change between baseline (within 2 weeks pre-intervention) and post-intervention (within 2 weeks post-intervention)
White matter plasticity	Change in white matter mean diffusivity measured with diffusion MRI	Change between baseline (within 2 weeks pre-intervention) and post-intervention (1 year follow-up)

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Dyslexia
• Other Study ID Numbers: 52231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No