Multiple Sclerosis Clinical Trial
Official title:
Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis
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.
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