Neurobiology and Treatment of Reading Disability in NF-1

NCT00624234 | Completed Results

• 2 other identifiers: R01NS049096NF1-R01
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 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.

Conditions

Neurofibromatosis Type 1; Reading Disabilities

Keywords

neurofibromatosis type 1; reading disabilities; NF-1; learning disabilities; tutoring intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Neuroimaging Data

  Collected before and after intervention

Study Arms (6)

NF-Tutoring Program 1

EXPERIMENTAL

Tutoring Program I

Behavioral: Tutoring Program I

NF-Tutoring Program 2

EXPERIMENTAL

Tutoring Program II

Behavioral: Tutoring Program II

Typically Developing Readers

NO INTERVENTION

Control group

IRD-Tutoring Program 1

EXPERIMENTAL

Tutoring Program I

Behavioral: Tutoring Program I

IRD-Tutoring Program 2

EXPERIMENTAL

Tutoring Program II

Behavioral: Tutoring Program II

Waitlist Control

NO INTERVENTION

Intervention Control Group (RD)

Interventions

Tutoring Program I BEHAVIORAL

Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design.

IRD-Tutoring Program 1; NF-Tutoring Program 1

Tutoring Program II BEHAVIORAL

Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity.

IRD-Tutoring Program 2; NF-Tutoring Program 2

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Vanderbilt University, Vanderbilt University Institute of Imaging Science

Nashville, Tennessee, 37232-2310, United States

Location

Related Links

• Additional study information

MeSH Terms

Conditions

Neurofibromatosis 1; Dyslexia; Learning Disabilities

Condition Hierarchy (Ancestors)

Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Specific Learning Disorder; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

Small sample size; Different group sizes; Random assignment to treatment group (along with small sample size) produced some asymmetry of pretest score by treatment group, such that the NF-Tutoring Program 2 started with a higher group mean score.

Results Point of Contact

• Title: Dr. Laurie Cutting
• Organization: Vanderbilt University

Laurie.Cutting@Vanderbilt.Edu

615-875-1054

Study Officials

• Laurie E. Cutting, Ph.D.

  Vanderbilt University Special Education Department

  PRINCIPAL INVESTIGATOR

• Martha Bridge Denckla, M.D.

  Kennedy Krieger Institute, Johns Hopkins University, Johns Hopkins University School of Medicine

  PRINCIPAL INVESTIGATOR

• Sheryl L. Rimrodt, M.D.

  Vanderbilt University Pediatrics Department

  PRINCIPAL INVESTIGATOR

• John Gore, Ph.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 25, 2008
• First Posted: February 27, 2008
• Study Start: February 1, 2006
• Primary Completion: March 1, 2013
• Study Completion: January 1, 2017
• Last Updated: July 8, 2025
• Results First Posted: April 10, 2017

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)