Clinical trial NCT02612935: An Observational Pilot Study of Lumosity Computerized Cognitive Training in Subjects With Multiple Sclerosis
Official title: An Observational Pilot Study of Lumosity Computerized Cognitive Training in Subjects With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis (MS)
Lead sponsor: Lumos Labs, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Dignity Health
First posted: 2015-11-24
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Performance Characteristics and Usability measures of Lumosity, as measured by Self-Report Descriptive Questionnaires
timeFrame: 1 year
Secondary outcomes:
measure: Efficacy of Lumosity in individuals with MS, as measured with the BPT
timeFrame: Change from baseline as measured at 3, 6, 9 and 12 months
measure: Efficacy of Lumosity in individuals with MS, as measured with the MSNQ
timeFrame: 1 Year
measure: Efficacy of Lumosity in individuals with MS, as measured with the MOCA
timeFrame: 1 Year
measure: Efficacy of Lumosity in individuals with MS, as measured with the MSIS-29.
timeFrame: 1 Year
measure: Efficacy of Lumosity in individuals with MS, as measured with the BDI.
timeFrame: 1 Year
measure: Engagement - as measured by number of unique days played and number of games played
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: MS Achievement Center
name: Brian Hutchinson
role: PRINCIPAL_INVESTIGATOR
References: