Using fMRI to Evaluate Instructional Programs for Children With Developmental Dyslexia

June 23, 2005 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Remediation in Developmental Dyslexia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: ECT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Guinevere F. Eden, Ph.D., Georgetown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Completion

May 1, 2005

Study Registration Dates

First Submitted

September 10, 2003

First Submitted That Met QC Criteria

September 10, 2003

First Posted (ESTIMATE)

September 11, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

November 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R01HD037890 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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