Digital Cognition in Multiple Sclerosis

NCT03569618 | Completed Results FDA Device

• 1 other identifier: 16-19891
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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)

Conditions

Multiple Sclerosis; Cognitive Decline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With at Least 4-point Increase in SDMT Above Their Baseline Value 8 Weeks After Treatment

  14 weeks

Other Outcomes (4)

• Change in Mood After 6 Weeks Treatment With Game 1 vs. Game 2

  Baseline and 6 weeks

• Change in Fatigue After 6 Weeks Treatment With Game 1 vs. Game 2.

  Baseline and 6 weeks

• Change in a Digital Cognitive Battery After 6 Weeks Treatment With Game 1 vs. Game 2.

  Baseline and 6 weeks

Study Arms (2)

Game 1

ACTIVE COMPARATOR

Tablet-based Game 1.

Device: Tablet-based Game

Game 2

PLACEBO COMPARATOR

Tablet-based Game 2.

Device: Tablet-based Game

Interventions

Tablet-based Game DEVICE

Tablet-based game aimed at improving processing speed and attention.

Game 1; Game 2

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Akili Interactive Labs, Inc.: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (3)

• 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.

  PMID: 32584155 RESULT

• 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.

  PMID: 34967751 DERIVED

• 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.

  PMID: 33470940 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Riley Bove, MD MSc
• Organization: University of California, San Francisco

riley.bove@ucsf.edu

415.502.7209

Study Officials

• Riley Bove, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study assessment administrator is blinded to what digital tool the subject has been assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: June 26, 2018
• Study Start: April 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: January 15, 2019
• Last Updated: October 26, 2020
• Results First Posted: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)