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Using fMRI to Evaluate Instructional Programs for Children With Developmental Dyslexia

This study is ongoing, but not recruiting participants.

Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00068835
  Purpose

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.


Condition Intervention
Developmental Dyslexia
Behavioral: Lindamood-Bell training for dyslexia

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Educational/Counseling/Training, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study
Official Title:   Remediation in Developmental Dyslexia

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment:   160
Study Start Date:   June 2000
Estimated Study Completion Date:   May 2005

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.

  Eligibility
Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068835

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

Sponsors and Collaborators

Investigators
Principal Investigator:     Guinevere F. Eden, Ph.D.     Georgetown University    
  More Information


Study ID Numbers:   5R01HD37890
First Received:   September 10, 2003
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00068835
Health Authority:   United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Reading  
Brain imaging  

Study placed in the following topic categories:
Signs and Symptoms
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Language Disorders
Dyslexia
Learning Disorders
Neurobehavioral Manifestations
Communication Disorders

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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