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Neural Mechanisms of Successful Intervention in Children With Dyslexia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323488
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Jason Yeatman, Stanford University

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.

Condition or disease Intervention/treatment Phase
Dyslexia, Developmental Behavioral: Lindamood-Bell Seeing Stars Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: subjects are seen before and after receiving 8 weeks of reading instruction
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neural Mechanisms of Successful Intervention in Children With Dyslexia
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

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.




Primary Outcome Measures :
  1. White matter plasticity [ Time Frame: Change between baseline (within 2 weeks pre-intervention) and post-intervention (within 2 weeks post-intervention) ]
    Change in white matter mean diffusivity measured with diffusion MRI

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



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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323488


Contacts
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Contact: Jason D Yeatman, PhD (650) 723-2109 jyeatman@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Jason Yeatman, PhD    650-723-2109    jyeatman@stanford.edu   
Sponsors and Collaborators
Stanford University
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Responsible Party: Jason Yeatman, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04323488    
Other Study ID Numbers: 52231
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslexia
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Learning Disorders
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders