Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis

Study Overview
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Brief Summary
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The effects of multiple sclerosis (MS) on cognition, thought to occur in 50-75% of persons with MS, have gained increasing recognition as one of the major disabling symptoms of the disease. While numerous studies have addressed the emotional and physical impact of MS, little attention has been given to strategies that might help manage the cognitive changes commonly experienced by persons with MS. The proposed study will test a novel computer-assisted cognitive rehabilitation intervention, MAPSS-MS (Memory, Attention, & Problem Solving Skills for Persons with MS). The MAPSS-MS integrates the powerful effects of group interventions to build self-efficacy for new cognitive compensatory strategies/behaviors with individual home-based computer-assisted training. The computer training will assist individuals to develop cognitive skills that they can apply to everyday life using the compensatory strategies learned in the class sessions. In the recently completed exploratory study with 61 persons with MS (R21NR011076), the eight-week MAPSS-MS intervention was acceptable and feasible and had medium to large effects on the use of compensatory strategies and performance on neuropsychological tests of verbal memory. The proposed study will test the refined MAPSS-MS intervention with a larger more diverse sample (N=180) across multiple sites, extend the period of post-intervention follow-up to 6 months and establish whether performance improvements on neuropsychological tests make the important transfer to improved neuro-cognitive functioning in everyday life. The specific aims of this study are to: (1) Evaluate the efficacy of the novel MAPSS-MS cognitive rehabilitation intervention to improve overall neuro-cognitive competence in activities of daily living including verbal memory performance, use of compensatory cognitive strategies and performance on cognitive-related instrumental activities of daily living (IADL) among persons with MS; (2) Evaluate the efficacy of the MAPSS-MS intervention to improve self-efficacy and related aspects of cognitive performance (non-verbal learning/memory, information processing speed and attention, verbal fluency and complex scanning and tracking) among persons with MS; and (3) Determine the number of intervention participants who achieve and maintain their self-identified cognitive goals three and six months following the intervention. The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with a comparison group receiving usual care computer games. Measurements of study variables will occur at baseline, immediately after the MAPSS-MS intervention, and three months and six months after the intervention is complete. Statistical analysis will include descriptive statistics and HLM analysis to account for the nested design. The intent-to-treat approach will be used. Public Health Statement: This research will provide new knowledge about an innovative intervention to improve memory, use of compensatory strategies, and performance of cognitive activities and instrumental activities of daily living for persons with MS. If effective, the intervention would provide a new and feasible approach to target a serious, debilitating problem commonly experienced by persons with MS.

Official Title
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Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: MAPSS-MS
* Other: Usual Care plus computer games


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically definite diagnosis of MS; Age 18 to 60; Capable of understanding and complying with the study protocol; Able to read and write in English; Visual acuity of at least 20/70 with correction in order to work on the computer screen; Stable disease at the time of entry into the study (relapse free for at least 90 days); Subjective concerns about their cognitive functioning (based on the Perceived Deficits Questionnaire); and Home internet access; Exclusion Criteria: Other medical causes of dementia or other neurological disorders that may impact cognition or emotions; Evidence of major psychiatric disorder; or Major functional limitations that preclude them from participating in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)<br>Participants randomized to this arm receive the MAPSS-MS intervention. The MAPSS-MS is an an 8 week computer assisted cognitive rehabilitation intervention. The group based component of the intervention emphasizes use of compensatory cognitive strategies as well as lifestyle modifications to enhance cognition. Participants also complete home computer training (minimum 3 times per week for 45 minutes) using a special suite of games designed by Lumosity. | Behavioral: MAPSS-MS<br>* MAPSS-MS is a computer-assisted cognitive rehabilitation intervention. It is a combination of home computer training and 8-weeks of group sessions on lifestyle change and compensatory cognitive strategies.<br>|
| Active Comparator: Usual Care plus Computer games<br>Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site. | Other: Usual Care plus computer games<br>* Participants assigned to this arm receive their usual medical care and referral to the My Brain Games website.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuro-cognitive competence in daily living - Verbal Memory | Verbal memory performance as measured by performance on the CVLT | 6 months post-intervention | 
| Use of Compensatory Cognitive Strategies | Scores on the Memory Compensatory Strategies Scale | 6 months post-intervention | 
| Cognitive-related instrumental activities of daily living (IADL) among persons with MS | Scores on the Everyday Problems Test - Revised | 6 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Efficacy | Scores on the general self-efficacy scale | 6 months post intervention | 
| Verbal fluency | Controlled Oral Word Association Test (COWAT) | 6 months post intervention | 
| Nonverbal learning and memory | Brief Visuospatial Memory Test, 2nd ed (BVMT-R) | 6 months post intervention | 
| Auditory information processing speed and flexibility | Paced Auditory Serial Addition Test (PASAT) | 6 months post intervention | 
| complex scanning and visual tracking | Symbol Digit Modalities Test (SDMT) | 6 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive rehabilitation