Multiple Sclerosis, Cognitive Impairment
Conditions
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.
Interventions
6 week course of cognitive rehabilitation focused on attention, learning, and memory
OTHERSham placebo
an alternative home-based computer program not designed for cognitive remediation but of the same duration
Sponsors
Horizon Blue Cross Blue Shield of New Jersey
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Placebo controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1\. Diagnosis of multiple sclerosis with cognitive complaint
Exclusion criteria
1. Patients unwilling to participate 2. Patients who cannot attend NPT sessions 3. Patients with severe cognitive impairment 4. Non-English speaking patients (testing materials are in English) 5. Patients with intact neuropsychological functioning at baseline on testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Functioning | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Utilization | 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 |
| Work Productivity and Activity Impairment Instrument | 6 months | Measures a person's impairments in their ability to work and participate in chosen activities |
| Hospital Anxiety and Depression Scale | 6 months | Measures depression and anxiety |
| Multiple Sclerosis Quality of Life Inventory | 6 months | A battery of quality of life scales designed for use by people with MS |
| Multiple Sclerosis Self-Efficacy Scale | 6 Months | Measures the person's perspective on maintenance and control over their multiple sclerosis |
Other
| Measure | Time frame | Description |
|---|---|---|
| Timed Up & Go Test | 6 months | A timed test of functional mobility that tests a persons ability to stand, walk a short distance and return to sitting. |
| Six-minute Walk Test | 6 months | A measure of walking endurance - measures how far a person can walk in six minutes |
Countries
United States
Contacts
Primary ContactVikram Bhise, MD
Outcome results
None listed