NCT02612935

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

November 19, 2015

Last Update Submit

May 23, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

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

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

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

    1 Year

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

    1 Year

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

    1 Year

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

    1 Year

  • +1 more secondary outcomes

Interventions

LumosityDEVICE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Participants must meet the following criteria:
  • Signed informed consent
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Brian Hutchinson

    MS Achievement Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 24, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

May 25, 2017

Record last verified: 2017-05