Trial Outcomes & Findings for Digital Cognition in Multiple Sclerosis (NCT NCT03569618)
NCT ID: NCT03569618
Last Updated: 2020-10-26
Results Overview
Processing speed is being measured by the Symbol Digit Modalities Test (SDMT) score. SDMT measures the time to pair abstract symbols with specific numbers. The test requires visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items in 90 seconds. (max=110, min=0). Higher scores indicate improvement. Lower scores indicate worsening.
COMPLETED
NA
44 participants
Baseline and 6 weeks
2020-10-26
Participant Flow
Participant milestones
| Measure |
AKL-T03
Tablet-based game aimed at improving processing speed and attention.
|
AKL-T09
Control, tablet-based word-finding game
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Digital Cognition in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
AKL-T03
n=23 Participants
Tablet-based game aimed at improving processing speed and attention.
|
AKL-T09
n=21 Participants
Control, tablet-based word finding game
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
49.2 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
51.1 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
21 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksProcessing speed is being measured by the Symbol Digit Modalities Test (SDMT) score. SDMT measures the time to pair abstract symbols with specific numbers. The test requires visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items in 90 seconds. (max=110, min=0). Higher scores indicate improvement. Lower scores indicate worsening.
Outcome measures
| Measure |
AKL-T03
n=20 Participants
Tablet-based game aimed at improving processing speed and attention.
|
AKL-T09
n=20 Participants
Control, tablet-based word-finding game
|
|---|---|---|
|
Change in Processing Speed After 6 Weeks of Treatment With a Digital Therapeutic 'Game 1', vs. 'Game 2'.
|
6.10 score on a scale
Standard Deviation 4.62
|
3.55 score on a scale
Standard Deviation 7.51
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: 39 participants (97.5%) returned for Visit 3
Number of participants showing a clinically meaningful 4+ point increase in SDMT (symbol digit modalities test) relative to baseline SDMT score. Comparison of SDMT changes 8 weeks after end of treatment with Tool 1 vs. Tool 2.
Outcome measures
| Measure |
AKL-T03
n=20 Participants
Tablet-based game aimed at improving processing speed and attention.
|
AKL-T09
n=19 Participants
Control, tablet-based word-finding game
|
|---|---|---|
|
Number of Participants With at Least 4-point Increase in SDMT Above Their Baseline Value 8 Weeks After Treatment
|
14 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 weeksPopulation: Missing data for 6 participants on trait anxiety (STAI-T), 3 per study group; as well as for 2 participants on depression (CES-D) and state anxiety (STAI-S) measures, 1 per study group.
Comparison of changes in mood (depression, anxiety). Depression measured using the Center for Epidemiologic Studies Depression Scale (CES-D). Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology. Anxiety measured using the State-Trait Anxiety Inventory - State subtest (STAI-S) and the State-Trait Anxiety Inventory - Trait subtest (STAI-T). Both have 20 questions and a score range 20-80, with higher scores indicating greater anxiety.
Outcome measures
| Measure |
AKL-T03
n=19 Participants
Tablet-based game aimed at improving processing speed and attention.
|
AKL-T09
n=19 Participants
Control, tablet-based word-finding game
|
|---|---|---|
|
Change in Mood After 6 Weeks Treatment With Game 1 vs. Game 2
Depression (CES-D)
|
1.11 score on a scale
Standard Deviation 6.14
|
-.90 score on a scale
Standard Deviation 5.57
|
|
Change in Mood After 6 Weeks Treatment With Game 1 vs. Game 2
Anxiety - State (STAI-S)
|
.05 score on a scale
Standard Deviation 4.64
|
.21 score on a scale
Standard Deviation 8.93
|
|
Change in Mood After 6 Weeks Treatment With Game 1 vs. Game 2
Anxiety - Trait (STAI-T)
|
.77 score on a scale
Standard Deviation 4.10
|
.35 score on a scale
Standard Deviation 3.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 weeksPopulation: Missing fatigue survey data (MFIS) for 2 participants, 1 per study group.
Fatigue is being measured by the Modified Fatigue Impact Scale (MFIS) which has participants rank 21 items on 1 to 4 (never to always) scale. The score is the sum of these subscales. (max=84, min=0) Lower scores indicate improvement. Higher scores indicate worsening.
Outcome measures
| Measure |
AKL-T03
n=19 Participants
Tablet-based game aimed at improving processing speed and attention.
|
AKL-T09
n=19 Participants
Control, tablet-based word-finding game
|
|---|---|---|
|
Change in Fatigue After 6 Weeks Treatment With Game 1 vs. Game 2.
|
-4.79 score on a scale
Standard Deviation 6.27
|
-2.95 score on a scale
Standard Deviation 9.55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 weeksPopulation: Match data was unavailable for some participants (n = 6, 3 per group)
Comparison of changes in scores on Match, a tablet-based assessment of processing speed and executive function. Performance is gauged on a continuous scale using the total number of correct responses given in 2-minutes. The minimum possible score is 0 (no correct responses) with higher scores indicating better performance (no maximum possible score).
Outcome measures
| Measure |
AKL-T03
n=17 Participants
Tablet-based game aimed at improving processing speed and attention.
|
AKL-T09
n=17 Participants
Control, tablet-based word-finding game
|
|---|---|---|
|
Change in a Digital Cognitive Battery After 6 Weeks Treatment With Game 1 vs. Game 2.
|
0.94 number of correct responses
Standard Deviation 3.54
|
0.35 number of correct responses
Standard Deviation 4.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 weeksPopulation: Missing PASAT data for 3 participants, 2 in AKL-T03 and 1 in AKL-T09. Data for other measures (SDMT, BVMT-R and CVLT-II) were collected from all participants.
Comparison of changes in cognition, as assessed using the BICAMS battery (Brief International Cognitive Assessment for Multiple Sclerosis) and PASAT (Paced Auditory Serial Addition Test). The BICAMS battery is composed of 3 tests (for all, higher scores indicate better performance): (1) The Symbol Digit Modalities Test (SDMT), a measure of information processing speed where performance is gauged by the number of correct responses given in 90-seconds, with a minimum possible score of 0 and maximum of 110. (2) The California Verbal Learning Test-II (CVLT-II) is a 5-trial auditory/verbal learning test with a total min. score of 0 and max of 80. (3) The Brief Visuospatial Memory Test -- Revised (BVMT-R) is a visual and spatial memory test given in 3 trials with a total min score of 0 and max of 36. The PASAT is a test of information processing and attention with a minimum score of 0 and maximum of 60. Higher scores indicate better performance.
Outcome measures
| Measure |
AKL-T03
n=20 Participants
Tablet-based game aimed at improving processing speed and attention.
|
AKL-T09
n=20 Participants
Control, tablet-based word-finding game
|
|---|---|---|
|
Change in Paper and Pencil Cognitive Testing After 6 Weeks Treatment With Game 1 vs. Game 2.
BVMT-R
|
0.70 score on a scale
Standard Deviation 4.47
|
3.25 score on a scale
Standard Deviation 5.23
|
|
Change in Paper and Pencil Cognitive Testing After 6 Weeks Treatment With Game 1 vs. Game 2.
PASAT
|
2.72 score on a scale
Standard Deviation 5.41
|
2.53 score on a scale
Standard Deviation 7.19
|
|
Change in Paper and Pencil Cognitive Testing After 6 Weeks Treatment With Game 1 vs. Game 2.
SDMT
|
6.10 score on a scale
Standard Deviation 4.62
|
3.55 score on a scale
Standard Deviation 7.51
|
|
Change in Paper and Pencil Cognitive Testing After 6 Weeks Treatment With Game 1 vs. Game 2.
CVLT-II
|
2.05 score on a scale
Standard Deviation 9.14
|
5.20 score on a scale
Standard Deviation 8.60
|
Adverse Events
AKL-T03
AKL-T09
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Riley Bove, MD MSc
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place