- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00068835
Using fMRI to Evaluate Instructional Programs for Children With Developmental Dyslexia
Remediation in Developmental Dyslexia
Study Overview
Status
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
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20057
- Georgetown University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: ECT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Collaborators and Investigators
Investigators
- Principal Investigator: Guinevere F. Eden, Ph.D., Georgetown University
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Developmental Dyslexia
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Georgia State UniversityMedical University of South Carolina; National Institutes of Health (NIH)CompletedDevelopmental Reading Disorder | Dyslexia, DevelopmentalUnited States
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IRCCS Eugenio MedeaCompletedDevelopmental Dyslexia | Developmental Spelling DisorderItaly
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University Hospital, ToulouseCompletedDevelopmental Dyslexia | Developmental Coordination DisorderFrance
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Ahmet EmirCompletedIntellectual Disability | Developmental Dyslexia | Developmental DisabilityTurkey
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Catholic University of the Sacred HeartFondazione Policlinico Universitario Agostino Gemelli IRCCS; Fondazione I.R...Enrolling by invitationDevelopmental DyslexiaItaly
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University of ZurichUnknown
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CNGE IRMG AssociationScalab CNRS 9193UnknownSpecific Learning Disorder | Developmental Coordination Disorder | Specific Developmental Disorders of Speech and Language | Dyslexia, Developmental | DyspraxiaFrance
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Bambino Gesù Hospital and Research InstituteRecruitingDevelopmental DyslexiaItaly
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Bambino Gesù Hospital and Research InstituteEnrolling by invitationDevelopmental DyslexiaItaly
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Scalab CNRS 9193UnknownDevelopmental DyslexiaFrance
Clinical Trials on Lindamood-Bell training for dyslexia
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Stanford UniversityEnrolling by invitationDyslexia, DevelopmentalUnited States
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University of Heidelberg Medical CenterUnknownDyslexia | Reading Disability | Reading Disorder | Developmental Reading DisorderGermany
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Hong Kong Baptist UniversityUniversity Grants Committee, Hong KongCompletedDyslexia | Special Education | Special Needs ChildrenHong Kong
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University Hospital, GenevaRecruiting
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The University of Texas Medical Branch, GalvestonNot yet recruitingStroke | Healthy VolunteersUnited States
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University of HartfordCompletedCerebral PalsyUnited States
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Future Generations Graduate SchoolUnited States Agency for International Development (USAID); Instituto de Investigacion...CompletedHealth Behavior | Infant Nutrition Disorders
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University of Southern DenmarkOdense Patient Data Explorative Network; Independent Research Fund DenmarkNot yet recruitingKnee Discomfort | Hypermobility, Joint | Hypermobility SyndromeDenmark
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Chang Gung Memorial HospitalCompletedCerebrovascular DisordersTaiwan
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Karolinska InstitutetCompleted