Trial Outcomes & Findings for Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis (NCT NCT03200899)
NCT ID: NCT03200899
Last Updated: 2024-07-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
183 participants
Primary outcome timeframe
6 months post-intervention
Results posted on
2024-07-10
Participant Flow
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.
Participant milestones
| Measure |
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: 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.
|
Usual Care Plus Computer Games
Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
Usual Care plus computer games: Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
90
|
|
Overall Study
T2 - Immediately Post-intervention
|
85
|
78
|
|
Overall Study
T3 - 3-months Post-intervention
|
82
|
74
|
|
Overall Study
COMPLETED
|
83
|
67
|
|
Overall Study
NOT COMPLETED
|
10
|
23
|
Reasons for withdrawal
| Measure |
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: 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.
|
Usual Care Plus Computer Games
Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
Usual Care plus computer games: Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
23
|
Baseline Characteristics
Computer Assisted Cognitive Rehabilitation for Persons With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)
n=93 Participants
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: 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.
|
Usual Care Plus Computer Games
n=90 Participants
Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
Usual Care plus computer games: Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
93 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
49.6 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
93 participants
n=5 Participants
|
90 participants
n=7 Participants
|
183 participants
n=5 Participants
|
|
Marital Status
Married
|
56 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Marital Status
Un-married
|
37 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Employment Status
Full-time
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Employment Status
Part-time
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Employment Status
Unemployed - Disability
|
32 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Employment Status
Retired
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Employment Status
Other
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Employment Status
Not reported
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Years Since Diagnosis
|
13.9 years
STANDARD_DEVIATION 8.05 • n=5 Participants
|
12.1 years
STANDARD_DEVIATION 8.07 • n=7 Participants
|
13.0 years
STANDARD_DEVIATION 8.08 • n=5 Participants
|
|
MS Type
Benign Sensory
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
MS Type
Relapsing-Remitting
|
64 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
MS Type
Primary Progressive
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
MS Type
Secondary Progressive
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
MS Type
Progressive-Relapsing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
MS Type
Unable to choose one/don't know
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
MS Type
Not reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Expanded Disability Status Scale (EDSS)
|
5.1 units on a scale
STANDARD_DEVIATION 1.63 • n=5 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 1.5 • n=7 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 1.56 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post-interventionVerbal 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.
Outcome measures
| Measure |
Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)
n=93 Participants
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: 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.
|
Usual Care Plus Computer Games
n=90 Participants
Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
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 - California Verbal Learning Test-II
|
56.1 units on a scale
Standard Deviation 12.9
|
53.6 units on a scale
Standard Deviation 12.9
|
PRIMARY outcome
Timeframe: 6 months post-interventionScores 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.
Outcome measures
| Measure |
Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)
n=93 Participants
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: 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.
|
Usual Care Plus Computer Games
n=90 Participants
Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
Usual Care plus computer games: Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.
|
|---|---|---|
|
Use of Compensatory Cognitive Strategies
|
40.2 units on a scale
Standard Deviation 11.0
|
39.5 units on a scale
Standard Deviation 11.2
|
PRIMARY outcome
Timeframe: 6 months post interventionScores 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.
Outcome measures
| Measure |
Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)
n=93 Participants
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: 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.
|
Usual Care Plus Computer Games
n=90 Participants
Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
Usual Care plus computer games: Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.
|
|---|---|---|
|
Cognitive-related Instrumental Activities of Daily Living (IADL) Among Persons With MS
|
24.2 units on a scale
Standard Deviation 4.8
|
23.5 units on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 6 months post interventionScores 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.
Outcome measures
| Measure |
Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)
n=93 Participants
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: 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.
|
Usual Care Plus Computer Games
n=90 Participants
Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
Usual Care plus computer games: Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.
|
|---|---|---|
|
Self-Efficacy
|
63.7 units on a scale
Standard Deviation 11.1
|
61.1 units on a scale
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: 6 months post interventionControlled 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.
Outcome measures
| Measure |
Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)
n=93 Participants
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: 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.
|
Usual Care Plus Computer Games
n=90 Participants
Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
Usual Care plus computer games: Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.
|
|---|---|---|
|
Verbal Fluency
|
39.5 words generated
Standard Deviation 12.1
|
36.9 words generated
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: 6 months post interventionBrief 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.
Outcome measures
| Measure |
Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)
n=93 Participants
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: 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.
|
Usual Care Plus Computer Games
n=90 Participants
Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
Usual Care plus computer games: Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.
|
|---|---|---|
|
Nonverbal Learning and Memory
|
21.9 units on a scale
Standard Deviation 7.0
|
20.1 units on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: 6 months post interventionThe 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.
Outcome measures
| Measure |
Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)
n=93 Participants
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: 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.
|
Usual Care Plus Computer Games
n=90 Participants
Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
Usual Care plus computer games: Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.
|
|---|---|---|
|
Auditory Information Processing Speed and Flexibility
|
47.6 units on a scale
Standard Deviation 11.9
|
45.9 units on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: 6 months post interventionThe 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.
Outcome measures
| Measure |
Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)
n=93 Participants
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: 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.
|
Usual Care Plus Computer Games
n=90 Participants
Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
Usual Care plus computer games: Participants assigned to this arm receive their usual medical care and referral to the "My Brain Games" website.
|
|---|---|---|
|
Psychomotor Processing Speed
|
54.6 units on a scale
Standard Deviation 12.2
|
52.0 units on a scale
Standard Deviation 12.4
|
Adverse Events
Memory, Attention, Problem Solving Skills in MS (MAPSS-MS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Plus Computer Games
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alexa Stuifbergen
The University of Texas at Austin
Phone: +1 (512) 471-4100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place