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Neural Mechanisms of Successful Intervention in Children With Dyslexia

Primary Purpose

Dyslexia, Developmental

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lindamood-Bell Seeing Stars
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dyslexia, Developmental

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lindamood-Bell Seeing Stars

Control

Arm Description

Subjects receive reading instruction focusing on the building blocks of reading

Subjects are followed longitudinally but do not receive intervention

Outcomes

Primary Outcome Measures

White matter plasticity
Change in white matter mean diffusivity measured with diffusion MRI
White matter plasticity
Change in white matter mean diffusivity measured with diffusion MRI

Secondary Outcome Measures

Full Information

First Posted
March 23, 2020
Last Updated
August 9, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04323488
Brief Title
Neural Mechanisms of Successful Intervention in Children With Dyslexia
Official Title
Neural Mechanisms of Successful Intervention in Children With Dyslexia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslexia, Developmental

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
subjects are seen before and after receiving 8 weeks of reading instruction
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lindamood-Bell Seeing Stars
Arm Type
Experimental
Arm Description
Subjects receive reading instruction focusing on the building blocks of reading
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects are followed longitudinally but do not receive intervention
Intervention Type
Behavioral
Intervention Name(s)
Lindamood-Bell Seeing Stars
Intervention Description
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.
Primary Outcome Measure Information:
Title
White matter plasticity
Description
Change in white matter mean diffusivity measured with diffusion MRI
Time Frame
Change between baseline (within 2 weeks pre-intervention) and post-intervention (within 2 weeks post-intervention)
Title
White matter plasticity
Description
Change in white matter mean diffusivity measured with diffusion MRI
Time Frame
Change between baseline (within 2 weeks pre-intervention) and post-intervention (1 year follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

Neural Mechanisms of Successful Intervention in Children With Dyslexia

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