Neurobiology and Treatment of Reading Disability in NF-1

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Brief Title

Neurobiology and Treatment of Reading Disability in NF-1

Official Title

Neurobiology and Treatment of Reading Disability in Neurofibromatosis Type 1 (NF-1)

Brief Summary

      The goal of this trial is to determine if children with neurofibromatosis type 1 who have
      reading disabilities respond the same way-both behaviorally and neurobiologically-to
      specialized treatment programs as children with idiopathic reading disabilities do, and to
      determine which intervention is best for particular learner profiles.
    

Detailed Description

      The most common concern of parents of children with neurofibromatosis type 1 (NF-1) is
      learning disabilities (LD). Approximately one half of all children with NF-1 have LD-the most
      debilitating and common of which are reading disabilities.

      The purpose of this study is to determine if children with NF-1 who have reading disabilities
      respond the same way-both behaviorally and neurobiologically-to specialized treatment
      programs known to improve the decoding deficits in children with idiopathic reading
      disabilities. The trial will also determine which intervention is best for particular learner
      profiles. The overall purpose of this research is to gain a deeper understanding of the
      characteristics and treatment of reading disabilities in NF-1.

      In the trial, researchers will compare children with NF-1 who show weaknesses in reading to
      children with reading disabilities of no known cause (idiopathic) using two different
      interventions and behavioral and neurobiological measures. Both interventions focus on
      teaching sound-symbol relationships, but vary in terms of relative emphasis on verbal versus
      visual methods of teaching.

      Scientists hope findings from the trial will advance knowledge about the best therapies for
      LD in children with NF-1. And, by further refining how children with NF-1 who have reading
      disabilities are similar (or different) to children with idiopathic reading disabilities, the
      researchers may be able to learn if reading interventions that address areas other than
      decoding will also benefit children with NF-1. Also, by understanding the similarities and/or
      differences in the neuropsychological and neurobiological profiles of children with NF-1 who
      have reading disabilities, and those without, scientists will be able to refine the cognitive
      phenotype and neurobiological characteristics of NF-1, which will further understanding of
      central nervous system abnormalities in NF-1.
    


Study Type

Interventional


Primary Outcome

Change From Baseline in WJ-III Basic Reading Normative Update (Woodcock Johnson Psychoeducational Battery - 3rd Edition; WJ-III NU) Standard Score at 15 Hours

Secondary Outcome

 Neuroimaging Data

Condition

Neurofibromatosis Type 1

Intervention

Tutoring Program I

Study Arms / Comparison Groups

 NF-Tutoring Program 1
Description:  Tutoring Program I

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

184

Start Date

February 2006

Completion Date

January 2017

Primary Completion Date

March 2013

Eligibility Criteria

        Inclusion Criteria:

        This study will be open to all individuals, ages 8 to 17 years, who meet eligibility
        criteria regardless of race, gender, or socioeconomic status.

          -  The Reading Disabilities group (including those with NF-1) is defined by scoring equal
             to or less than the 25th percentile on measures of basic word reading skills.

          -  The Control group (including those with NF1) is defined by scoring equal to or above
             the 40th percentile on the average of the Letter Word Identification and Word Attack
             subtests from the WJ-III.

        Exclusion Criteria:

        Any child, regardless of which group he/she is recruited for, will be excluded if he/she
        meets any of the following criteria (determined during phone screening, medical review, and
        during testing):

          -  is in foster care;

          -  previous diagnosis of mental retardation;

          -  known uncorrectable visual impairment;

          -  history of known neurological disorder (e.g., epilepsy, spina bifida, cerebral palsy,
             traumatic brain injury);

          -  documented hearing impairment greater than 25 dB loss in either ear;

          -  medical contraindication to MRI procedures, if participating in MRI (including
             exposure to metal and pregnancy);

          -  individuals known to have an IQ below 70;

          -  history or presence of a pervasive developmental disorder;

          -  during the DICA-IV parents indicate the presence of any severe psychiatric diagnoses
             or pervasive developmental disorder.
      

Gender

All

Ages

8 Years - 17 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Laurie E. Cutting, Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00624234

Organization ID

R01NS049096

Secondary IDs

NF1-R01

Responsible Party

Principal Investigator

Study Sponsor

Vanderbilt University

Collaborators

 National Institute of Neurological Disorders and Stroke (NINDS)

Study Sponsor

Laurie E. Cutting, Ph.D., Principal Investigator, Vanderbilt University Special Education Department


Verification Date

July 2021