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

Primary Purpose

Neurofibromatosis Type 1

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CogmedRM
Mobymax
Sponsored by
Kristina Hardy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurofibromatosis Type 1

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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 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:

  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

Sites / Locations

  • Children's National Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cogmed

MobyMax

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in CogState One-back subtest
Computerized task of working memory

Secondary Outcome Measures

Change in Attention Deficit Hyperactive Disorder- Rating Scale
Parent-completed rating scale
Change in Wechsler Intelligence Scale for Children-Fifth Edition-Integrated Spatial Span Backward
Visual-spatial working memory task
Change in Wechsler Intelligence Scale for Children-Fifth Edition-Integrated Digit Span Backward
Auditory working memory task
CogState One-card Learning
Computerized attention and executive functioning tasks
Change in Behavior Rating Inventory of Executive Functioning (BRIEF) Working Memory Index
Parent-completed questionnaire
Change in Test of Word Reading Efficiency-Second Edition (TOWRE-2) Scores
Child-completed reading task
Change in Test of Everyday Reading Comprehension (TERC) Scores
Child-completed reading task
Change in Behavior Rating Inventory of Executive Functioning (BRIEF) Metacognition Index
Parent-completed questionnaire
CogState Groton Maze Learning Task
Computerized task of executive functioning
Change in Wechsler Intelligence Scale for Children-Fifth Edition-Integrated Letter-Number Sequencing
Auditory working memory task

Full Information

First Posted
May 25, 2016
Last Updated
March 2, 2022
Sponsor
Kristina Hardy
Collaborators
Children's National Health System, Royal Children's Hospital, Children's Hospital Los Angeles, Sydney Children's Hospitals Network
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1. Study Identification

Unique Protocol Identification Number
NCT02944032
Brief Title
Efficacy of Computerized Cognitive Training and Stimulant Medication in Neurofibromatosis Type 1
Acronym
COGTRAIN
Official Title
Multimodal Intervention Trial for Cognitive Deficits in Neurofibromatosis Type 1: Efficacy of Computerized Cognitive Training and Stimulant Medication
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
September 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kristina Hardy
Collaborators
Children's National Health System, Royal Children's Hospital, Children's Hospital Los Angeles, Sydney Children's Hospitals Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofibromatosis Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cogmed
Arm Type
Experimental
Arm Description
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.
Arm Title
MobyMax
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CogmedRM
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mobymax
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in CogState One-back subtest
Description
Computerized task of working memory
Time Frame
From baseline to end of training, up to 11 weeks
Secondary Outcome Measure Information:
Title
Change in Attention Deficit Hyperactive Disorder- Rating Scale
Description
Parent-completed rating scale
Time Frame
From baseline to end of training, up to 11 weeks
Title
Change in Wechsler Intelligence Scale for Children-Fifth Edition-Integrated Spatial Span Backward
Description
Visual-spatial working memory task
Time Frame
From baseline to end of training, up to 11 weeks
Title
Change in Wechsler Intelligence Scale for Children-Fifth Edition-Integrated Digit Span Backward
Description
Auditory working memory task
Time Frame
From baseline to end of training, up to 11 weeks
Title
CogState One-card Learning
Description
Computerized attention and executive functioning tasks
Time Frame
From baseline to end of training, up to 11 weeks
Title
Change in Behavior Rating Inventory of Executive Functioning (BRIEF) Working Memory Index
Description
Parent-completed questionnaire
Time Frame
From baseline to end of training, up to 11 weeks
Title
Change in Test of Word Reading Efficiency-Second Edition (TOWRE-2) Scores
Description
Child-completed reading task
Time Frame
From baseline to end of training, up to 11 weeks
Title
Change in Test of Everyday Reading Comprehension (TERC) Scores
Description
Child-completed reading task
Time Frame
From baseline to end of training, up to 11 weeks
Title
Change in Behavior Rating Inventory of Executive Functioning (BRIEF) Metacognition Index
Description
Parent-completed questionnaire
Time Frame
From baseline to end of training, up to 11 weeks
Title
CogState Groton Maze Learning Task
Description
Computerized task of executive functioning
Time Frame
From baseline to end of training, up to 11 weeks
Title
Change in Wechsler Intelligence Scale for Children-Fifth Edition-Integrated Letter-Number Sequencing
Description
Auditory working memory task
Time Frame
From baseline to end of training, up to 11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Hardy, PhD
Organizational Affiliation
Children's National Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Health System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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