Computerized Cognitive Rehabilitation in MS Patients
Primary Purpose
Multiple Sclerosis, Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized cognitive rehabilitation
Sham placebo
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of multiple sclerosis with cognitive complaint
Exclusion Criteria:
- Patients unwilling to participate
- Patients who cannot attend NPT sessions
- Patients with severe cognitive impairment
- Non-English speaking patients (testing materials are in English)
- Patients with intact neuropsychological functioning at baseline on testing
Sites / Locations
- Robert Wood Johnson Medical SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intervention
Placebo
Arm Description
Computerized Cognitive Rehabilitation
Video game
Outcomes
Primary Outcome Measures
Cognitive Functioning
Compare between groups differences in attention (auditory and visual working memory), processing speed (automatic and controlled speed), executive functioning (verbal fluency and mental flexibility), and memory (immediate and delayed verbal and visual modalities) at completion of intervention, 3 months and 6 months using standardized scores.
Secondary Outcome Measures
Multiple Sclerosis Self-Efficacy Scale
Measures the person's perspective on maintenance and control over their multiple sclerosis
Work Productivity and Activity Impairment Instrument
Measures a person's impairments in their ability to work and participate in chosen activities
Multiple Sclerosis Quality of Life Inventory
A battery of quality of life scales designed for use by people with MS
Hospital Anxiety and Depression Scale
Measures depression and anxiety
Healthcare Utilization
Compare between group differences in annual cost of care, ER visits, hospital visits, hospital length of stay, number of preventive visits, total number of claims, and neurology office visits
Full Information
NCT ID
NCT03729713
First Posted
November 1, 2018
Last Updated
November 16, 2022
Sponsor
Rutgers, The State University of New Jersey
Collaborators
Horizon Blue Cross Blue Shield of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT03729713
Brief Title
Computerized Cognitive Rehabilitation in MS Patients
Official Title
Computerized Cognitive Rehabilitation in MS Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
Horizon Blue Cross Blue Shield of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study examines a home-based computerized cognitive rehabilitation intervention in adults with multiple sclerosis compared to placebo (videogame). Patients are assessed through pre-and post neuropsychological testing.
Detailed Description
Patients will be randomized to enter a 6 week course of computer based cognitive rehabilitation focused on improving attention, learning, and memory. Control patients will receive an alternative home-based computer program not designed for cognitive remediation but of the same duration.
The primary outcome will be performance on neuropsychological testing in the intervention sample compared to controls. Secondary outcomes will be the measures of self-efficacy, work productivity, quality of life, fatigue, depression, anxiety, and healthcare utilization. Healthcare utilization variables include annual total cost (current year and prior), number and cost of ER/hospital/outpatient visits, number of hospital visits, hospital length of stay, number preventive visits, total number claims, and number of new medications initiated. In addition, acute changes in neuropsychological testing induced by a bout of physical activity (i.e. self-paced walking during the Six-Minute Walk Test) will be examined, and that pattern of change will be compared between intervention and control groups at each data collection point.
Each subject will participate for a total of 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Placebo controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Computerized Cognitive Rehabilitation
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Video game
Intervention Type
Other
Intervention Name(s)
Computerized cognitive rehabilitation
Intervention Description
6 week course of cognitive rehabilitation focused on attention, learning, and memory
Intervention Type
Other
Intervention Name(s)
Sham placebo
Intervention Description
an alternative home-based computer program not designed for cognitive remediation but of the same duration
Primary Outcome Measure Information:
Title
Cognitive Functioning
Description
Compare between groups differences in attention (auditory and visual working memory), processing speed (automatic and controlled speed), executive functioning (verbal fluency and mental flexibility), and memory (immediate and delayed verbal and visual modalities) at completion of intervention, 3 months and 6 months using standardized scores.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Multiple Sclerosis Self-Efficacy Scale
Description
Measures the person's perspective on maintenance and control over their multiple sclerosis
Time Frame
6 Months
Title
Work Productivity and Activity Impairment Instrument
Description
Measures a person's impairments in their ability to work and participate in chosen activities
Time Frame
6 months
Title
Multiple Sclerosis Quality of Life Inventory
Description
A battery of quality of life scales designed for use by people with MS
Time Frame
6 months
Title
Hospital Anxiety and Depression Scale
Description
Measures depression and anxiety
Time Frame
6 months
Title
Healthcare Utilization
Description
Compare between group differences in annual cost of care, ER visits, hospital visits, hospital length of stay, number of preventive visits, total number of claims, and neurology office visits
Time Frame
12 Months
Other Pre-specified Outcome Measures:
Title
Six-minute Walk Test
Description
A measure of walking endurance - measures how far a person can walk in six minutes
Time Frame
6 months
Title
Timed Up & Go Test
Description
A timed test of functional mobility that tests a persons ability to stand, walk a short distance and return to sitting.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of multiple sclerosis with cognitive complaint
Exclusion Criteria:
Patients unwilling to participate
Patients who cannot attend NPT sessions
Patients with severe cognitive impairment
Non-English speaking patients (testing materials are in English)
Patients with intact neuropsychological functioning at baseline on testing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vikram Bhise, MD
Phone
7322357875
Email
MSCogStudy@outlook.com
Facility Information:
Facility Name
Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08091
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikram Bhise, MD
Phone
732-235-7875
First Name & Middle Initial & Last Name & Degree
Vikram Bhise, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Computerized Cognitive Rehabilitation in MS Patients
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