Computerized Cognitive Rehabilitation in MS Patients
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|ClinicalTrials.gov Identifier: NCT03729713|
Recruitment Status : Enrolling by invitation
First Posted : November 5, 2018
Last Update Posted : May 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Cognitive Impairment||Other: Computerized cognitive rehabilitation Other: Sham placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Placebo controlled|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Computerized Cognitive Rehabilitation in MS Patients|
|Actual Study Start Date :||April 21, 2021|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||May 2023|
Computerized Cognitive Rehabilitation
Other: Computerized cognitive rehabilitation
6 week course of cognitive rehabilitation focused on attention, learning, and memory
Sham Comparator: Placebo
Other: Sham placebo
an alternative home-based computer program not designed for cognitive remediation but of the same duration
- Cognitive Functioning [ Time Frame: 6 Months ]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.
- Multiple Sclerosis Self-Efficacy Scale [ Time Frame: 6 Months ]Measures the person's perspective on maintenance and control over their multiple sclerosis
- Work Productivity and Activity Impairment Instrument [ Time Frame: 6 months ]Measures a person's impairments in their ability to work and participate in chosen activities
- Multiple Sclerosis Quality of Life Inventory [ Time Frame: 6 months ]A battery of quality of life scales designed for use by people with MS
- Hospital Anxiety and Depression Scale [ Time Frame: 6 months ]Measures depression and anxiety
- Healthcare Utilization [ Time Frame: 12 Months ]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
- Six-minute Walk Test [ Time Frame: 6 months ]A measure of walking endurance - measures how far a person can walk in six minutes
- Timed Up & Go Test [ Time Frame: 6 months ]A timed test of functional mobility that tests a persons ability to stand, walk a short distance and return to sitting.
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): NCT03729713
|United States, New Jersey|
|Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08091|