- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02944032
Efficacy of Computerized Cognitive Training and Stimulant Medication in Neurofibromatosis Type 1 (COGTRAIN)
Multimodal Intervention Trial for Cognitive Deficits in Neurofibromatosis Type 1: Efficacy of Computerized Cognitive Training and Stimulant Medication
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cognitive deficits are the most important cause of long-term dysfunction in patients with Neurofibromatosis type 1 (NF1). Among the most frequently-occurring difficulties are problems with attention, working memory (WM), and executive functioning (EF). Remediation and interventions to improve those deficits have the potential to impact the quality of life and long-term prognosis in this population. Cognitive training (CT) programs have increasingly been used independently or in conjunction with pharmacotherapies in children with accidental or disease-related brain injury. CogmedRM is both the most well-researched and widely-used CT program for remediation of WM deficits. Results from numerous randomized, controlled trials conducted with a variety of pediatric and adult patient populations generally show that CogmedRM training is associated with robust gains in performance-based WM scores over the short term, with some variability in improvement across disease groups. A single arm pilot study of CogmedRM in a sample of children with NF1 conducted at Children's National Medical Center has shown that the approach is likely feasible and acceptable to families.
Because many children with NF1 are treated with stimulant medications, and there is biological evidence that both CT and Methylphenidate act on dopaminergic systems, the investigators are also interested in examining whether or not there is a synergistic effect between these widely available and safe interventions. Thus, the aim is to assess the efficacy of a home-based, computerized cognitive training (CT) program in a sample of 90 children aged 8-16 with NF1 and working memory difficulties. This study will be conducted over the span of four years. If the participant qualifies following baseline testing, he/she will be randomized to the intervention, CogmedRM, or the active control condition, MobyMax (an online reading program). The participant will have 5-9 weeks to complete the program and will have follow-up testing 2 weeks after finishing the program. If CT, either singly or in combination with stimulant medication, can be shown to be efficacious in a sample of NF1 pediatric patients at high risk for neurocognitive deficits, this intervention plan could be rapidly translated to clinical practice.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 8-16 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.
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cogmed
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.
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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.
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Active Comparator: MobyMax
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in CogState One-back subtest
Time Frame: From baseline to end of training, up to 11 weeks
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Computerized task of working memory
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From baseline to end of training, up to 11 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Attention Deficit Hyperactive Disorder- Rating Scale
Time Frame: From baseline to end of training, up to 11 weeks
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Parent-completed rating scale
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From baseline to end of training, up to 11 weeks
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Change in Wechsler Intelligence Scale for Children-Fifth Edition-Integrated Spatial Span Backward
Time Frame: From baseline to end of training, up to 11 weeks
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Visual-spatial working memory task
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From baseline to end of training, up to 11 weeks
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Change in Wechsler Intelligence Scale for Children-Fifth Edition-Integrated Digit Span Backward
Time Frame: From baseline to end of training, up to 11 weeks
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Auditory working memory task
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From baseline to end of training, up to 11 weeks
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CogState One-card Learning
Time Frame: From baseline to end of training, up to 11 weeks
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Computerized attention and executive functioning tasks
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From baseline to end of training, up to 11 weeks
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Change in Behavior Rating Inventory of Executive Functioning (BRIEF) Working Memory Index
Time Frame: From baseline to end of training, up to 11 weeks
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Parent-completed questionnaire
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From baseline to end of training, up to 11 weeks
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Change in Test of Word Reading Efficiency-Second Edition (TOWRE-2) Scores
Time Frame: From baseline to end of training, up to 11 weeks
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Child-completed reading task
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From baseline to end of training, up to 11 weeks
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Change in Test of Everyday Reading Comprehension (TERC) Scores
Time Frame: From baseline to end of training, up to 11 weeks
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Child-completed reading task
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From baseline to end of training, up to 11 weeks
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Change in Behavior Rating Inventory of Executive Functioning (BRIEF) Metacognition Index
Time Frame: From baseline to end of training, up to 11 weeks
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Parent-completed questionnaire
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From baseline to end of training, up to 11 weeks
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CogState Groton Maze Learning Task
Time Frame: From baseline to end of training, up to 11 weeks
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Computerized task of executive functioning
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From baseline to end of training, up to 11 weeks
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Change in Wechsler Intelligence Scale for Children-Fifth Edition-Integrated Letter-Number Sequencing
Time Frame: From baseline to end of training, up to 11 weeks
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Auditory working memory task
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From baseline to end of training, up to 11 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kristina Hardy, PhD, Children's National Health System
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Neoplasms, Nerve Tissue
- Peripheral Nervous System Diseases
- Nervous System Neoplasms
- Heredodegenerative Disorders, Nervous System
- Neoplastic Syndromes, Hereditary
- Nerve Sheath Neoplasms
- Neurocutaneous Syndromes
- Peripheral Nervous System Neoplasms
- Neurofibromatoses
- Neurofibromatosis 1
- Neurofibroma
Other Study ID Numbers
- 00007343
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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