An interventional study of MAPSS-MS and Usual Care plus computer games in Multiple Sclerosis, sponsored by University of Texas at Austin. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-07-10.
Sponsored by University of Texas at Austin · Not applicable, Interventional, and Supportive care
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 183 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of Texas at Austin is the lead sponsor of 319 studies on the registry; 78 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
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Exclusion Criteria:
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
Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
Other: Usual Care plus computer games
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.
Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.
Neuro-cognitive Competence in Daily Living - California Verbal Learning Test-II
Verbal memory performance (verbal learning and remembering) as measured by performance on the California Verbal Learning Test II (CVLT-II). Total score represents the number of words recalled from a 16 item list over 5 trials. Higher scores represent greater verbal learning and remembering. Scores can range from 0 to 80.
Time frame: 6 months post-intervention
Use of Compensatory Cognitive Strategies
Scores on the Strategy Subscale of the Multi-Factorial Memory Memory Questionnaire. The subscale includes 19 various memory aids and strategies and respondents are asked to rate how frequently they used each strategy during the past 2 weeks using a 5 point scale (never to all the time). Scores can range from 0 to 76. HIgher scores indicate greater use of compensatory memory strategies.
Time frame: 6 months post-intervention
Cognitive-related Instrumental Activities of Daily Living (IADL) Among Persons With MS
Scores on the Everyday Problems Test - Revised (EPT-R). This scale assess the cognitive ability to reason and solve problems encountered in daily living. The revised version included 30 items and scores can range from 0 to 30. HIgher scores indicate better performance on problem solving.
Time frame: 6 months post intervention
Self-Efficacy
Scores on the 17 item general self-efficacy scale. Respondents rate their confidence in their ability to affect outcomes in various contexts and situations using a 5-point Likert scale. Scores can range from 17 to 85 with higher scores representing greater perceived self-efficacy expectations.
Time frame: 6 months post intervention
Verbal Fluency
Controlled Oral Word Association Test (COWAT) is a measure of verbal fluency and word finding. It requires participants to generate words from initial letters (normally F, A and S) under time constraints, normally 60 seconds per letter. The score reflects the number of words generated across the trials and can vary from 0 to the maximum number generated. Higher scores reflect a greater number of words and greater fluency and word finding.
Time frame: 6 months post intervention
Nonverbal Learning and Memory
Brief Visuospatial Memory Test, 2nd ed (BVMT-R) asses visuospatial memory and was used as a measure of non-verbal learning and memory. The total recall score was used in this study and this score represents the sum of all valid items generated across learning trials 1-3. In each trial, 0-12 points can be obtained. The recognition (yes/no) is scored by one or zero points with a maximum of 12 points. The total score for the total recall ranges from 0 to 36. HIgher scores indicate better memory and recall.
Time frame: 6 months post intervention
Auditory Information Processing Speed and Flexibility
The Paced Auditory Serial Addition Test (PASAT) - 3 second was used as the measure of auditory information processing speed and flexibility. Scores represent the number of correct responses during the 3 minute test and can range from 0 to 60. Higher scores indicate better information processing speed and flexibility.
Time frame: 6 months post intervention
Psychomotor Processing Speed
The Symbol Digit Modalities Test (SDMT) was used to measure psychomotor processing speed, complex scanning and visual tracking. Respondents have 90 seconds to pair digits/numbers with abstract geometric symbols. Total scores represent the number of correct matches within the time period and can range from 0 to 110. Higher scores reflect better information processing speed.
Time frame: 6 months post intervention
Participants were recruited from three large metropolitan communities in Texas: Houston, San Antonio and Dallas. Participants were recruited via physician referral, targeted mailings to persons with MS on the mailing list of the National MS Society, contact with support groups, and notices in MS newletters and websites.
| Milestone | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games |
|---|---|---|
| Started | 93 | 90 |
| T2 - immediately post-intervention | 85 | 78 |
| T3 - 3-months post-intervention | 82 | 74 |
| Completed | 83 | 67 |
| Not completed | 10 | 23 |
| Withdrew: Lost to follow-up | 10 | 23 |
Verbal memory performance (verbal learning and remembering) as measured by performance on the California Verbal Learning Test II (CVLT-II). Total score represents the number of words recalled from a 16 item list over 5 trials. Higher scores represent greater verbal learning and remembering. Scores can range from 0 to 80.
| units on a scale | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games |
|---|---|---|
| Neuro-cognitive Competence in Daily Living - California Verbal Learning Test-II | 56.1 ± 12.9 | 53.6 ± 12.9 |
Scores on the Strategy Subscale of the Multi-Factorial Memory Memory Questionnaire. The subscale includes 19 various memory aids and strategies and respondents are asked to rate how frequently they used each strategy during the past 2 weeks using a 5 point scale (never to all the time). Scores can range from 0 to 76. HIgher scores indicate greater use of compensatory memory strategies.
| units on a scale | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games |
|---|---|---|
| Use of Compensatory Cognitive Strategies | 40.2 ± 11.0 | 39.5 ± 11.2 |
Scores on the Everyday Problems Test - Revised (EPT-R). This scale assess the cognitive ability to reason and solve problems encountered in daily living. The revised version included 30 items and scores can range from 0 to 30. HIgher scores indicate better performance on problem solving.
| units on a scale | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games |
|---|---|---|
| Cognitive-related Instrumental Activities of Daily Living (IADL) Among Persons With MS | 24.2 ± 4.8 | 23.5 ± 4.4 |
Scores on the 17 item general self-efficacy scale. Respondents rate their confidence in their ability to affect outcomes in various contexts and situations using a 5-point Likert scale. Scores can range from 17 to 85 with higher scores representing greater perceived self-efficacy expectations.
| units on a scale | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games |
|---|---|---|
| Self-Efficacy | 63.7 ± 11.1 | 61.1 ± 12.0 |
Controlled Oral Word Association Test (COWAT) is a measure of verbal fluency and word finding. It requires participants to generate words from initial letters (normally F, A and S) under time constraints, normally 60 seconds per letter. The score reflects the number of words generated across the trials and can vary from 0 to the maximum number generated. Higher scores reflect a greater number of words and greater fluency and word finding.
| words generated | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games |
|---|---|---|
| Verbal Fluency | 39.5 ± 12.1 | 36.9 ± 11.9 |
Brief Visuospatial Memory Test, 2nd ed (BVMT-R) asses visuospatial memory and was used as a measure of non-verbal learning and memory. The total recall score was used in this study and this score represents the sum of all valid items generated across learning trials 1-3. In each trial, 0-12 points can be obtained. The recognition (yes/no) is scored by one or zero points with a maximum of 12 points. The total score for the total recall ranges from 0 to 36. HIgher scores indicate better memory and recall.
| units on a scale | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games |
|---|---|---|
| Nonverbal Learning and Memory | 21.9 ± 7.0 | 20.1 ± 6.7 |
The Paced Auditory Serial Addition Test (PASAT) - 3 second was used as the measure of auditory information processing speed and flexibility. Scores represent the number of correct responses during the 3 minute test and can range from 0 to 60. Higher scores indicate better information processing speed and flexibility.
| units on a scale | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games |
|---|---|---|
| Auditory Information Processing Speed and Flexibility | 47.6 ± 11.9 | 45.9 ± 11.8 |
The Symbol Digit Modalities Test (SDMT) was used to measure psychomotor processing speed, complex scanning and visual tracking. Respondents have 90 seconds to pair digits/numbers with abstract geometric symbols. Total scores represent the number of correct matches within the time period and can range from 0 to 110. Higher scores reflect better information processing speed.
| units on a scale | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games |
|---|---|---|
| Psychomotor Processing Speed | 54.6 ± 12.2 | 52.0 ± 12.4 |
Collected over 8 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | 0/93 (0%) | 0/93 (0%) | 0/93 (0%) |
| Usual Care Plus Computer Games | 0/90 (0%) | 0/90 (0%) | 0/90 (0%) |
| Age, Categorical(Participants) | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 93 | 90 | 183 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games | Total |
|---|---|---|---|
| Mean | 49.8 ± 7.5 | 49.4 ± 8.5 | 49.6 ± 8.0 |
| Sex: Female, Male(Participants) | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games | Total |
|---|---|---|---|
| Female | 80 | 80 | 160 |
| Male | 13 | 10 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 9 | 18 |
| Not Hispanic or Latino | 84 | 81 | 165 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 17 | 17 | 34 |
| White | 73 | 64 | 137 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 3 | 8 | 11 |
| Region of Enrollment(participants) | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games | Total |
|---|---|---|---|
| United States | 93 | 90 | 183 |
| Marital Status(Participants) | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games | Total |
|---|---|---|---|
| Married | 56 | 61 | 117 |
| Un-married | 37 | 29 | 66 |
| Employment Status(Participants) | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games | Total |
|---|---|---|---|
| Full-time | 25 | 28 | 53 |
| Part-time | 5 | 3 | 8 |
| Unemployed - Disability | 32 | 39 | 71 |
| Retired | 12 | 5 | 17 |
| Other | 8 | 2 | 10 |
| Not reported | 11 | 13 | 24 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data files will be de-identified and data will be available on request to the investigators - estimated availability 2020
Supporting information: Study protocol, Sap, Analytic code
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University of Texas at Austin