Clinical trial NCT03569618: Digital Cognition in Multiple Sclerosis
Official title: Effect of a Digital Therapeutic on Processing Speed in Adults With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Cognitive Decline
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Akili Interactive Labs, Inc.
First posted: 2018-06-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: The purpose of this study is to begin to test a brain training video game in people with Multiple Sclerosis (MS).

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).

Eligibility 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.

Primary outcomes:
measure: Change in Processing Speed After 6 Weeks of Treatment With a Digital Therapeutic 'Game 1', vs. 'Game 2'.
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Number of Participants With at Least 4-point Increase in SDMT Above Their Baseline Value 8 Weeks After Treatment
timeFrame: 14 weeks
Other outcomes:
measure: Change in Mood After 6 Weeks Treatment With Game 1 vs. Game 2
timeFrame: Baseline and 6 weeks
measure: Change in Fatigue After 6 Weeks Treatment With Game 1 vs. Game 2.
timeFrame: Baseline and 6 weeks
measure: Change in a Digital Cognitive Battery After 6 Weeks Treatment With Game 1 vs. Game 2.
timeFrame: Baseline and 6 weeks
measure: Change in Paper and Pencil Cognitive Testing After 6 Weeks Treatment With Game 1 vs. Game 2.
timeFrame: Baseline and 6 weeks
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Riley Bove, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.