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| Name | Class |
|---|---|
| Horizon Blue Cross Blue Shield of New Jersey | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Computerized Cognitive Rehabilitation |
|
| Placebo | Sham Comparator | Video game |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized cognitive rehabilitation | Other | 6 week course of cognitive rehabilitation focused on attention, learning, and memory |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple Sclerosis Self-Efficacy Scale | Measures the person's perspective on maintenance and control over their multiple sclerosis | 6 Months |
| Work Productivity and Activity Impairment Instrument |
| Measure | Description | Time Frame |
|---|---|---|
| Six-minute Walk Test | A measure of walking endurance - measures how far a person can walk in six minutes | 6 months |
| Timed Up & Go Test | A timed test of functional mobility that tests a persons ability to stand, walk a short distance and return to sitting. |
Inclusion Criteria:
1. Diagnosis of multiple sclerosis with cognitive complaint
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vikram Bhise, MD | Contact | 7322357875 | MSCogStudy@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson Medical School | Recruiting | New Brunswick | New Jersey | 08091 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Placebo controlled
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| Sham placebo | Other | an alternative home-based computer program not designed for cognitive remediation but of the same duration |
|
Measures a person's impairments in their ability to work and participate in chosen activities
| 6 months |
| Multiple Sclerosis Quality of Life Inventory | A battery of quality of life scales designed for use by people with MS | 6 months |
| Hospital Anxiety and Depression Scale | Measures depression and anxiety | 6 months |
| 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 | 12 Months |
| 6 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |