Study Results
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View full resultsBasic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2018-04-01
2019-01-15
Brief Summary
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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)
Detailed Description
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Visit 1. After informed consent, you will complete a series of questions about your functioning and mood. You will then complete a series of tests (vision, hand tapping, walking). Then, you will complete a set of thinking tests. The first set will be paper and pencil. The second set will be on a tablet or a computer. You will use your study code to sign into these tools and you won't provide any personal details for the digitized tests.
Finally, you will complete the "cognitive training tool". There are two versions of this digital, iPad based tool, which takes about 25 minutes to complete and is designed to be entertaining. You will be randomized into 1 of 2 groups: each group will play a version of the brain training game. You will not be told what group/game type you were randomized into. You will be given the tablet with the game on it to take home, and to practice this game 5 times a week for 6 weeks.
Visit 2. After the 6 weeks of at-home training, you will then come back to the research study unit to do a repeat of the initial visit (with physical and cognitive assessments). At this study visit, you will also be returning the iPad.
Visit 3. You will then return 8 weeks after Visit 2, to do a repeat of the assessments.
You will be compensated for each study visit (visit 1: $50, visit 2: $100, visit 3: $150).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Game 1
Tablet-based Game 1.
Tablet-based Game
Tablet-based game aimed at improving processing speed and attention.
Game 2
Tablet-based Game 2.
Tablet-based Game
Tablet-based game aimed at improving processing speed and attention.
Interventions
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Tablet-based Game
Tablet-based game aimed at improving processing speed and attention.
Eligibility Criteria
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Inclusion Criteria
* 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
* A clinical relapse within the last 30 days.
* Steroid treatment for clinical relapse within the last 30 days.
18 Years
71 Years
ALL
No
Sponsors
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Akili Interactive Labs, Inc.
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Riley Bove, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California San Francisco
San Francisco, California, United States
Countries
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References
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Bove R, Rowles W, Zhao C, Anderson A, Friedman S, Langdon D, Alexander A, Sacco S, Henry R, Gazzaley A, Feinstein A, Anguera JA. A novel in-home digital treatment to improve processing speed in people with multiple sclerosis: A pilot study. Mult Scler. 2021 Apr;27(5):778-789. doi: 10.1177/1352458520930371. Epub 2020 Jun 25.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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16-19891
Identifier Type: -
Identifier Source: org_study_id