Digital Cognition in Multiple Sclerosis (DigCog)

Effect of a Digital Therapeutic on Processing Speed in Adults With Multiple Sclerosis

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)

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Cognitive Decline
• Intervention / Treatment: Device: Tablet-based Game

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).

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Game 1; Tablet-based Game 1.	Device: Tablet-based Game; Tablet-based game aimed at improving processing speed and attention.
Placebo Comparator: Game 2; Tablet-based Game 2.	Device: Tablet-based Game; Tablet-based game aimed at improving processing speed and attention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Processing Speed After 6 Weeks of Treatment With a Digital Therapeutic 'Game 1', vs. 'Game 2'.	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.	Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With at Least 4-point Increase in SDMT Above Their Baseline Value 8 Weeks After Treatment	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.	14 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mood After 6 Weeks Treatment With Game 1 vs. Game 2	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.	Baseline and 6 weeks
Change in Fatigue After 6 Weeks Treatment With Game 1 vs. Game 2.	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.	Baseline and 6 weeks
Change in a Digital Cognitive Battery After 6 Weeks Treatment With Game 1 vs. Game 2.	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).	Baseline and 6 weeks
Change in Paper and Pencil Cognitive Testing After 6 Weeks Treatment With Game 1 vs. Game 2.	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.	Baseline and 6 weeks

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Akili Interactive Labs, Inc.

Publications and helpful links

General Publications

• 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. Erratum In: J Med Internet Res. 2021 Jan 27;23(1):e27440.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 23, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurocognitive Disorders; Cognition Disorders; Multiple Sclerosis; Sclerosis; Cognitive Dysfunction
• Other Study ID Numbers: 16-19891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No