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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis (MS)
• Intervention / Treatment: Device: Lumosity

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 88

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

Participants must meet the following criteria:

1. Signed informed consent
2. 18 years of age or older,
3. English-speaking,
4. Current participants in the MS Achievement Center Cognitive Wellness Program
5. Sufficient physical capacity to use a computer keyboard and mouse
6. 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:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance Characteristics and Usability measures of Lumosity, as measured by Self-Report Descriptive Questionnaires	The primary objective is to determine performance characteristics and usability of Lumosity in individuals with MS as measured through qualitative questionnaires.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Lumosity in individuals with MS, as measured with the BPT	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	Change from baseline as measured at 3, 6, 9 and 12 months
Efficacy of Lumosity in individuals with MS, as measured with the MSNQ	To determine the efficacy of Lumosity in this study population as measured by • Change from baseline on the MSNQ at 12 months	1 Year
Efficacy of Lumosity in individuals with MS, as measured with the MOCA	To determine the efficacy of Lumosity in this study population as measured by • Change from baseline on the MOCA at 12 months	1 Year
Efficacy of Lumosity in individuals with MS, as measured with the MSIS-29.	To determine the efficacy of Lumosity in this study population as measured by • Change from baseline on the MSIS-29 at 12 months	1 Year
Efficacy of Lumosity in individuals with MS, as measured with the BDI.	To determine the efficacy of Lumosity in this study population as measured by • Change from baseline on the BDI at 12 months	1 Year
Engagement - as measured by number of unique days played and number of games played	To determine the level of engagement with Lumosity in individuals with MS as measured by number of unique days and number of games played	1 year

Collaborators and Investigators

• Sponsor: Lumos Labs, Inc.
• Collaborators: Dignity Health
• Investigators: Principal Investigator: Brian Hutchinson, MS Achievement Center

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (ACTUAL): February 1, 2017
• Study Completion (ACTUAL): February 1, 2017

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (ESTIMATE): November 24, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: LL009 - MS ACHIEVEMENT STUDY