Neural Mechanisms of Successful Intervention in Children With Dyslexia

Sponsor

Stanford University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04323488

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslexia, Developmental	Behavioral: Lindamood-Bell Seeing Stars	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

subjects are seen before and after receiving 8 weeks of reading instructionsubjects 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

Actual Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

White matter plasticity [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
White matter plasticity [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jason Yeatman, Assistant Professor, Stanford University

ClinicalTrials.gov Identifier:

NCT04323488

Other Study ID Numbers:

52231

First Posted:

Mar 26, 2020

Last Update Posted:

Aug 12, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dyslexia

Study Results

No Results Posted as of Aug 12, 2021