Digital Cognition in Multiple Sclerosis
Effect of a Digital Therapeutic on Processing Speed in Adults With Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Tablet-based Game
Results by group
Change in Processing Speed After 6 Weeks of Treatment With a Digital Therapeutic 'Game 1', vs. 'Game 2'.
Baseline and 6 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| AKL-T03 | 6.10 score on a scale | 4.62 (Standard Deviation) | 20 |
| AKL-T09 | 3.55 score on a scale | 7.51 (Standard Deviation) | 20 |
AKL-T03
AKL-T09
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| AKL-T03 | 20 | 0 (0.0%) | 0 |
| AKL-T09 | 20 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change in Processing Speed After 6 Weeks of Treatment With a Digital Therapeutic 'Game 1', vs. 'Game 2'.
Baseline and 6 weeks
Thinking and memory
Other measures (1)
Number of Participants With at Least 4-point Increase in SDMT Above Their Baseline Value 8 Weeks After Treatment
14 weeks
Thinking and memory
Who could take part
Early (CIS/RIS) · 18 to 71
Show the full criteria
Inclusion criteria
* Adult men or women diagnosed with multiple sclerosis (MS) or clinically isolated syndrome (CIS) * SDMT z-score range (-2 to +1) * Wifi available in home * Able to use a tablet (iPad) * Able to attend 3 study visits in person.
Exclusion criteria
* Clinician's assessment of visual, cognitive, or motor impairment that would preclude participation. * A clinical relapse within the last 30 days. * Steroid treatment for clinical relapse within the last 30 days.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
A DIGITAL THERAPEUTIC TO IMPROVE THINKING IN MULTIPLE SCLEROSIS WHO: 65 participants with a confirmed diagnosis of Multiple Sclerosis (MS) WHY: Purpose of the study is to compare the effect of 2 tablet-based brain training digital tools on important components of thinking (cognition). WHAT: Complete a set of tests (physical and cognitive) at baseline, 6 weeks and 14 weeks, and use one of two brain training tools on an iPad in your home, for 25 minutes a day, 5 days a week, for 6 weeks. WHERE: UCSF WEILL INSTITUTE FOR NEUROSCIENCES (675 Nelson Rising Lane, San Francisco, CA)
Papers
Results
A novel in-home digital treatment to improve processing speed in people with multiple sclerosis: A pilot study.Mult Scler · 2021
Results
Hsu WY, Rowles W, Anguera JA, Anderson A, Younger JW, Friedman S, Gazzaley A, Bove R. Assessing Cognitive Function in Multiple Sclerosis With Digital Tools: Observational Study. J Med Internet Res. 2021 Dec 30;23(12):e25748. doi: 10.2196/25748.Results
Hsu WY, Rowles W, Anguera JA, Zhao C, Anderson A, Alexander A, Sacco S, Henry R, Gazzaley A, Bove R. Application of an Adaptive, Digital, Game-Based Approach for Cognitive Assessment in Multiple Sclerosis: Observational Study. J Med Internet Res. 2021 Jan 20;23(1):e24356. doi: 10.2196/24356.
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History
Started
Apr 2018
Main results due
Nov 2018
Finished
Jan 2019
Results posted
Oct 2020