Computerized Cognitive Rehabilitation in MS Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Computerized Cognitive Rehabilitation in MS Patients

Conditions
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Multiple Sclerosis, Cognitive Impairment

Intervention / Treatment
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* Other: Computerized cognitive rehabilitation
* Other: Sham placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Placebo controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Computerized Cognitive Rehabilitation | Other: Computerized cognitive rehabilitation<br>* 6 week course of cognitive rehabilitation focused on attention, learning, and memory<br>|
| Sham Comparator: Placebo<br>Video game | Other: Sham placebo<br>* an alternative home-based computer program not designed for cognitive remediation but of the same duration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |