Clinical trial NCT00624234: Neurobiology and Treatment of Reading Disability in NF-1
Official title: Neurobiology and Treatment of Reading Disability in Neurofibromatosis Type 1 (NF-1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurofibromatosis Type 1
Reading Disabilities
Keywords: neurofibromatosis type 1
reading disabilities
NF-1
learning disabilities
tutoring intervention
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-02-27
Enrollment: 184
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline in WJ-III Basic Reading Normative Update (Woodcock Johnson Psychoeducational Battery - 3rd Edition; WJ-III NU) Standard Score at 15 Hours
timeFrame: 0 and 15 hours
Secondary outcomes:
measure: Neuroimaging Data
timeFrame: Collected before and after intervention
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University, Vanderbilt University Institute of Imaging Science
state: Tennessee
Study officials:
affiliation: Vanderbilt University Special Education Department
name: Laurie E. Cutting, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kennedy Krieger Institute, Johns Hopkins University, Johns Hopkins University School of Medicine
name: Martha Bridge Denckla, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Pediatrics Department
name: Sheryl L. Rimrodt, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: John Gore, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: