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OpenTrials
Completed

NCT Number: NCT02612935

An Observational Pilot Study of Lumosity Computerized Cognitive Training in Subjects With Multiple Sclerosis

In collaboration with the Mercy MS Achievement Center, Lumos Labs is proposing an open-label, 12-month pilot study of computerized cognitive training as part of the cognitive wellness program in order to evaluate (1) the user experience of Lumosity in individuals with MS, and (2) the efficacy of Lumosity for improving cognitive outcomes in individuals with MS.

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Key information

Conditions

Multiple Sclerosis (MS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Approximately 50 current members of the Mercy MS Achievement Center will be provided with 12-month premium access Lumosity accounts. Study participants must be ≥18 years of age, and currently members of the Achievement Center participating in the cognitive wellness program. Those who consent will be provided with an account activation code and instructed on how to sign up for Lumosity.

Upon creating an account, users would be asked to complete a short demographic survey (Information About You, which includes age, sex, race/ethnicity, education, occupation) and two additional short surveys: a Computer Experience Questionnaire and a Perceptions of Brain Training questionnaire. In addition, participants will be assessed with the Montreal Cognitive Assessment (MOCA), and be directed to take the Brain Performance Test (on a laptop or desktop computer) within the first 7 days of creating their account. If not conducted within the previous 3 months, participants would also be required to have the following assessments at baseline (i.e., within the first 7 days): Multiple Sclerosis Neuropsychological Questionnaire (MSNQ), Multiple Sclerosis Impact Scale-29 (MSIS-29), and Beck Depression Inventory (BDI). After one week of using Lumosity, and then every other month for 12 months, participants would be asked to complete a short questionnaire about their experience with Lumosity. Every 3 months, participants would repeat the BPT, MSNQ, and BDI; and every 6 months, they would repeat the MSIS. Finally, at the end of the study, the end of the study they would also repeat the MOCA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants must meet the following criteria:

  • Signed informed consent
  • 18 years of age or older,
  • English-speaking,
  • Current participants in the MS Achievement Center Cognitive Wellness Program
  • Sufficient physical capacity to use a computer keyboard and mouse
  • Willing and able to use Lumosity at least 3 times per week

Exclusion criteria

Participants who meet any of the following criteria will be excluded from participation:

  • Under 18 years of age
  • Are taking medication that may impede cognitive functioning
  • Have other conditions or problems that may preclude regular computer usage

Treatment and study plan

Lumosity

Device

Lumosity offers a suite of online games focused on stimulating cognitive domains of attention, memory, cognitive flexibility, problem solving, and speed of processing. The Lumosity program may be well suited for cognitive remediation in individuals with MS.

Primary outcomes

  1. Performance Characteristics and Usability measures of Lumosity, as measured by Self-Report Descriptive Questionnaires

    Time frame: 1 year

    The primary objective is to determine performance characteristics and usability of Lumosity in individuals with MS as measured through qualitative questionnaires.

Secondary outcomes

  1. Efficacy of Lumosity in individuals with MS, as measured with the BPT

    Time frame: Change from baseline as measured at 3, 6, 9 and 12 months

    To determine the efficacy of Lumosity in this study population as measured by change from baseline on the BPT Grand Index score and scaled subtest scores at 3, 6, 9, and 12 months

  2. Efficacy of Lumosity in individuals with MS, as measured with the MSNQ

    Time frame: 1 Year

    To determine the efficacy of Lumosity in this study population as measured by

    • Change from baseline on the MSNQ at 12 months

  3. Efficacy of Lumosity in individuals with MS, as measured with the MOCA

    Time frame: 1 Year

    To determine the efficacy of Lumosity in this study population as measured by

    • Change from baseline on the MOCA at 12 months

  4. Efficacy of Lumosity in individuals with MS, as measured with the MSIS-29.

    Time frame: 1 Year

    To determine the efficacy of Lumosity in this study population as measured by

    • Change from baseline on the MSIS-29 at 12 months

  5. Efficacy of Lumosity in individuals with MS, as measured with the BDI.

    Time frame: 1 Year

    To determine the efficacy of Lumosity in this study population as measured by

    • Change from baseline on the BDI at 12 months

  6. Engagement - as measured by number of unique days played and number of games played

    Time frame: 1 year

    To determine the level of engagement with Lumosity in individuals with MS as measured by number of unique days and number of games played

Sponsors and collaborators

Lead sponsor

Lumos Labs, Inc.

Industry

Collaborators

  • Dignity Health

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 24, 2015
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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