Efficacy of Computerized Cognitive Training and Stimulant Medication in Neurofibromatosis Type 1

NCT02944032 | Completed

• 1 other identifier: 00007343
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to assess the efficacy of a home-based, computerized cognitive training (CT) program, called CogmedRM, targeted to improve working memory in children with NF1 and working memory difficulties. This is a Phase II randomized parallel group controlled clinical trial comparing two interventions on cognitive outcomes. Participants will be stratified by stimulant medication use and randomized equally between the two interventions within stratum. Participants will be in the study for to 11 weeks.

Conditions

Neurofibromatosis Type 1

Outcome Measures

Primary Outcomes (1)

• Change in CogState One-back subtest

  Computerized task of working memory

  From baseline to end of training, up to 11 weeks

Secondary Outcomes (10)

• Change in Attention Deficit Hyperactive Disorder- Rating Scale

  From baseline to end of training, up to 11 weeks

• Change in Wechsler Intelligence Scale for Children-Fifth Edition-Integrated Spatial Span Backward

  From baseline to end of training, up to 11 weeks

• Change in Wechsler Intelligence Scale for Children-Fifth Edition-Integrated Digit Span Backward

  From baseline to end of training, up to 11 weeks

• CogState One-card Learning

  From baseline to end of training, up to 11 weeks

• Change in Behavior Rating Inventory of Executive Functioning (BRIEF) Working Memory Index

  From baseline to end of training, up to 11 weeks

Study Arms (2)

Cogmed

EXPERIMENTAL

Cogmed RM is a computer program that consists of twelve visually-engaging and interesting exercises that target skills involving visuo-spatial and verbal Working Memory. During the intervention, children complete 25 training sessions. Children are asked to complete between 3 and 5 sessions per week, so the total treatment time to complete 25 sessions may range from 5 to 9 weeks. For children completing CogmedRM, sessions typically last between 25 and 45 minutes, depending on the child's working memory span.

Other: CogmedRM

MobyMax

ACTIVE COMPARATOR

MobyMax's "Reading Stories" program is a program that focuses on reading comprehension skills. Participants will start their training with stories that are matched to their reading "grade" level. Each grade contains 30 lessons, with 3 stories in each lesson. Participants are given questions to answer at the conclusion of each story, and children advance or remain at that level depending on the progression of their reading skill. Participants randomized to this program will be asked to train 30-45 minutes per session for 25 training sessions over a 5 to 9 week period.

Other: Mobymax

Interventions

CogmedRM OTHER

Cogmed RM is a computer program that consists of twelve visually-engaging and interesting exercises that target skills involving visuo-spatial and verbal Working Memory. Difficulty of the tasks is automatically adjusted on a trial-by-trial basis throughout each training session to match a child's current working memory span, such that as the child becomes more proficient, the exercises become more difficult. During the intervention, children complete 25 training sessions. Children are asked to complete between 3 and 5 sessions per week, so the total treatment time to complete 25 sessions may range from 5 to 9 weeks. For children completing CogmedRM, sessions typically last between 25 and 45 minutes, depending on the child's working memory span.

Cogmed

Mobymax OTHER

MobyMax's "Reading Stories" program is a program that focuses on reading comprehension skills. Participants will start their training with stories that are matched to their reading "grade" level. Each grade contains 30 lessons, with 3 stories in each lesson. Participants are given questions to answer at the conclusion of each story, and children advance or remain at that level depending on the progression of their reading skill. Participants randomized to this program will be asked to train 30-45 minutes per session for 25 training sessions over a 5 to 9 week period.

MobyMax

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old at time of screening
• NF1 Diagnosis based on National Institute of Health (NIH) criteria
• Has an identified caregiver who is willing and able to oversee the training practice during the intervention period
• Has access to a telephone and phone number where they can be reached
• Both patient and caregiver have reading, speaking, and listening comprehension of English
• Treated with a stable dose of stimulant medication for at least the last 30 days and not planning to change the dose during study participation or receiving no stimulant medications for at least the last 30 days and not planning to initiate a trial of stimulant medications for the duration of the study.
• \>1 Standard Deviation (SD) below the mean on the WISC-V-Integrated Spatial Span Backwards task or a Spatial Span Backwards score \>1 SD below the participant's estimated IQ.

You may not qualify if:

• Full scale IQ\<70, as estimated by WASI-II (Block Design, Vocabulary, Matrix Reasoning, Similarities).
• Note: In cases where there is a statistically significant difference between verbal IQ and performance IQ (.05 level as determined by the WASI-II manual), participants will be eligible if at least one of these quotients is 70 or above
• Current treatment for intracranial lesions, progressive tumors as per MRI evaluation or treatment with chemotherapy within the past 6 months
• A motor, visual, or auditory handicap that prevents computer use

Sponsors & Collaborators

• Kristina Hardy: lead
• Children's National Research Institute: collaborator
• Royal Children's Hospital: collaborator
• Children's Hospital Los Angeles: collaborator
• Sydney Children's Hospitals Network: collaborator

Study Sites (1)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Neurofibromatosis 1

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

Study Officials

• Kristina Hardy, PhD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: October 25, 2016
• Study Start: May 1, 2016
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)