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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02612935
Other study ID # LL009 - MS ACHIEVEMENT STUDY
Secondary ID
Status Completed
Phase N/A
First received November 19, 2015
Last updated May 23, 2017
Start date March 2015
Est. completion date February 2017

Study information

Verified date May 2017
Source Lumos Labs, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Lumos Labs, Inc. Dignity Health

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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