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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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Start Date
April 21, 2021
Primary Completion Date
May 1, 2023
Completion Date
May 1, 2024
Last Updated
November 17, 2022
80
ESTIMATED participants
Computerized cognitive rehabilitation
OTHER
Sham placebo
OTHER
Lead Sponsor
Rutgers, The State University of New Jersey
Collaborators
NCT07225504
NCT06276634
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07220668