Neurofibromatosis Type 1 Clinical Trial
Official title:
Neurobiology and Treatment of Reading Disability in Neurofibromatosis Type 1 (NF-1)
Verified date | April 2023 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 184 |
Est. completion date | January 2017 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 17 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University, Vanderbilt University Institute of Imaging Science | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in WJ-III Basic Reading Normative Update (Woodcock Johnson Psychoeducational Battery - 3rd Edition; WJ-III NU) Standard Score at 15 Hours | This metric measures change in reading abilities, including word recognition and decoding, as assessed by standard educational assessments (Woodcock Johnson Psychoeducational Battery - 3rd Edition Normative Update; WJ-III NU). The scores are reported as change in age-normed standard scores (a change of 15 standard score points would represent a change of 1 standard deviation in the general population).The Basic Reading score is a normed composite of the WJ-III subtests Letter-Word Identification and Word Attack, representing word-level reading skill. | 0 and 15 hours | |
Secondary | Neuroimaging Data | Neuroimaging data consists of functional MRI and structural MRI measures. | Collected before and after intervention |
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