Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis
|ClinicalTrials.gov Identifier: NCT03200899|
Recruitment Status : Unknown
Verified November 2017 by Alexa Stuifbergen, University of Texas at Austin.
Recruitment status was: Active, not recruiting
First Posted : June 27, 2017
Last Update Posted : November 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: MAPSS-MS Other: Usual Care plus computer games||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Masking Description:||Care providers are not informed of the participant's participation in a particular arm. Staff collecting outcome data are not aware of the participant's assignment to intervention or usual care.|
|Primary Purpose:||Supportive Care|
|Official Title:||Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis|
|Actual Study Start Date :||January 2014|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||June 2018|
Experimental: Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)
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.
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.
Active Comparator: Usual Care plus Computer games
Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
Other: Usual Care plus computer games
Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.
- Neuro-cognitive competence in daily living - Verbal Memory [ Time Frame: 6 months post-intervention ]Verbal memory performance as measured by performance on the CVLT
- Use of Compensatory Cognitive Strategies [ Time Frame: 6 months post-intervention ]Scores on the Memory Compensatory Strategies Scale
- Cognitive-related instrumental activities of daily living (IADL) among persons with MS [ Time Frame: 6 months post intervention ]Scores on the Everyday Problems Test - Revised
- Self-Efficacy [ Time Frame: 6 months post intervention ]Scores on the general self-efficacy scale
- Verbal fluency [ Time Frame: 6 months post intervention ]Controlled Oral Word Association Test (COWAT)
- Nonverbal learning and memory [ Time Frame: 6 months post intervention ]Brief Visuospatial Memory Test, 2nd ed (BVMT-R)
- Auditory information processing speed and flexibility [ Time Frame: 6 months post intervention ]Paced Auditory Serial Addition Test (PASAT)
- complex scanning and visual tracking [ Time Frame: 6 months post intervention ]Symbol Digit Modalities Test (SDMT)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200899
|United States, Texas|
|The University of Texas at Austin|
|Austin, Texas, United States, 78701|
|Principal Investigator:||Alexa Stuifbergen, PhD||University of Texas at Austin|