Using fMRI to Evaluate Instructional Programs for Children With Developmental Dyslexia

Developmental Dyslexia Clinical Trial

Official title:

Remediation in Developmental Dyslexia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00068835
• Other study ID #: 5R01HD037890
• Status: Active, not recruiting
• Phase: N/A
• First received: September 10, 2003
• Last updated: June 23, 2005
• Start date: June 2000
• Est. completion date: May 2005

Study information

• Verified date: November 2004
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Developmental Dyslexia
• Dyslexia

Intervention

Behavioral:
• Lindamood-Bell training for dyslexia

Locations

Country	Name	City	State
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States,