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

NCT ID: NCT02612935

Last Updated: 2017-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-02-28

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.

Conditions

Multiple Sclerosis (MS)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Lumosity

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dignity Health

OTHER

Sponsor Role: collaborator

Lumos Labs, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Hutchinson

Role: PRINCIPAL_INVESTIGATOR

MS Achievement Center

Other Identifiers

LL009 - MS ACHIEVEMENT STUDY

Identifier Type: -

Identifier Source: org_study_id