Clinical Trials Directory

Trials / Completed

CompletedNCT03200899

Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
183 (actual)
Sponsor
University of Texas at Austin · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMAPSS-MSMAPSS-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.
OTHERUsual Care plus computer gamesParticipants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.

Timeline

Start date
2014-01-01
Primary completion
2018-03-01
Completion
2018-06-01
First posted
2017-06-27
Last updated
2024-07-10
Results posted
2024-07-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03200899. Inclusion in this directory is not an endorsement.