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

This study is currently recruiting participants.
Verified March 2017 by Children's Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02944032
First Posted: October 25, 2016
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Children's National Health System
Boston Children’s Hospital
Royal Children's Hospital
Children's Hospital Los Angeles
Information provided by (Responsible Party):
Children's Research Institute
  Purpose
Th 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.

Condition Intervention
Neurofibromatosis Type 1 Other: CogmedRM Other: Mobymax

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multimodal Intervention Trial for Cognitive Deficits in Neurofibromatosis Type 1: Efficacy of Computerized Cognitive Training and Stimulant Medication

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

Primary Outcome Measures:
  • Change in CogState One-back subtest [ Time Frame: From baseline to end of training, up to 11 weeks ]
    Computerized task of working memory


Secondary Outcome Measures:
  • Change in Attention Deficit Hyperactive Disorder- Rating Scale [ Time Frame: From baseline to end of training, up to 11 weeks ]
    Parent-completed rating scale

  • 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 ]
    Visual-spatial working memory task

  • 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 ]
    Auditory working memory task

  • CogState One-card Learning [ Time Frame: From baseline to end of training, up to 11 weeks ]
    Computerized attention and executive functioning tasks

  • Change in Behavior Rating Inventory of Executive Functioning (BRIEF) Working Memory Index [ Time Frame: From baseline to end of training, up to 11 weeks ]
    Parent-completed questionnaire

  • Change in Test of Word Reading Efficiency—Second Edition (TOWRE-2) Scores [ Time Frame: From baseline to end of training, up to 11 weeks ]
    Child-completed reading task

  • Change in Test of Everyday Reading Comprehension (TERC) Scores [ Time Frame: From baseline to end of training, up to 11 weeks ]
    Child-completed reading task

  • Change in Behavior Rating Inventory of Executive Functioning (BRIEF) Metacognition Index [ Time Frame: From baseline to end of training, up to 11 weeks ]
    Parent-completed questionnaire

  • CogState Groton Maze Learning Task [ Time Frame: From baseline to end of training, up to 11 weeks ]
    Computerized task of executive functioning

  • 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 ]
    Auditory working memory task


Estimated Enrollment: 130
Study Start Date: May 2016
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: CogmedRM
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.
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.
Other: 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.

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, and executive functioning. 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 8-16 years old at time of screening
  2. NF1 Diagnosis based on National Institute of Health (NIH) criteria
  3. Has an identified caregiver who is willing and able to oversee the training practice during the intervention period
  4. Has access to a telephone and phone number where they can be reached
  5. Both patient and caregiver have reading, speaking, and listening comprehension of English
  6. 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.
  7. >1 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:

  1. 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

  2. Current treatment for intracranial lesions, progressive tumors as per MRI evaluation or treatment with chemotherapy within the past 6 months
  3. A motor, visual, or auditory handicap that prevents computer use
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944032


Contacts
Contact: Kristina Hardy, PhD 202-476-2514 KKHardy@childrensnational.org
Contact: Katie Olson, PsyD 202-476-4008 Kaolson@childrensnational.org

Locations
United States, District of Columbia
Children's National Health System Recruiting
Washington, District of Columbia, United States, 20010
Contact: Maria Acosta, MD    202-476-5111      
Contact: Kristina Hardy, PhD    202-476-5111      
Sponsors and Collaborators
Children's Research Institute
Children's National Health System
Boston Children’s Hospital
Royal Children's Hospital
Children's Hospital Los Angeles
  More Information

Responsible Party: Children's Research Institute
ClinicalTrials.gov Identifier: NCT02944032     History of Changes
Other Study ID Numbers: 00007343
First Submitted: May 25, 2016
First Posted: October 25, 2016
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Neurofibromatoses
Neurofibroma
Neurofibromatosis 1
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
Genetic Diseases, Inborn
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs