Using fMRI to Evaluate Instructional Programs for Children With Developmental Dyslexia
Primary Purpose
Developmental Dyslexia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lindamood-Bell training for dyslexia
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Developmental Dyslexia focused on measuring Reading, Brain imaging
Eligibility Criteria
Inclusion Criteria Developmental dyslexia diagnosis English speaking Right-handed General good health Exclusion Criteria Metal implant, braces, or other device that prevents child from undergoing fMRI
Sites / Locations
- Georgetown University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00068835
First Posted
September 10, 2003
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00068835
Brief Title
Using fMRI to Evaluate Instructional Programs for Children With Developmental Dyslexia
Official Title
Remediation in Developmental Dyslexia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2004
Overall Recruitment Status
Unknown status
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. Study Description
Brief Summary
Dyslexia is a common reading disorder. Specialized instructional programs can improve reading ability in children with dyslexia. This study will use functional magnetic resonance imaging (fMRI) to examine changes in the brains of children who have taken part in these programs.
Detailed Description
Reading is a uniquely human endeavor and failure to develop this skill can lead to serious educational and emotional consequences. Reading more slowly or less accurately, as is the case in developmental dyslexia, occurs in between 5% and 15% of individuals in the United States. Developmental dyslexia significantly interferes with academic achievement and with activities of daily living that require reading skills. Although dyslexia is considered a reading disorder, dyslexia's clinical signs are varied and include deficits in the sensory domain, abnormal phonological awareness, and problems in related linguistic skills. Phonological awareness training and visual perceptual training can improve reading ability in children with dyslexia. Recent functional imaging studies on sensory and language processing in dyslexia have demonstrated involvement of the posterior temporal and inferior parietal cortical systems of the brain. However, how these brain areas are changed as a result of dyslexia treatment has not been determined.
This study will investigate the neurophysiologic changes before and after treatment in 11- to 14-year-old children immersed in Lindamood-Bell training utilizing either phonological (LiPS) or visual (Seeing Stars) strategies. These training programs have successful behavioral outcomes, but neurophysiologic changes have not been evaluated. The study will determine whether behavioral changes in reading skills result in physiological differences in the brain identifiable with functional brain imaging and whether initial physiological observations are indicative of the degree of success of the intervention.
Participant will be randomized to receive either Lindamood-Bell training, a math intervention (active control), or no intervention (passive control). The intervention will last 6 weeks; children will have both pre- and post-intervention behavioral testing and fMRI scans.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Dyslexia
Keywords
Reading, Brain imaging
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Lindamood-Bell training for dyslexia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Developmental dyslexia diagnosis
English speaking
Right-handed
General good health
Exclusion Criteria
Metal implant, braces, or other device that prevents child from undergoing fMRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guinevere F. Eden, Ph.D.
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Using fMRI to Evaluate Instructional Programs for Children With Developmental Dyslexia
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