An Online Study of the Reliability of the Brain Performan... | NCT02403609

Studies
An Online Study of the Reliability of the Brain Performance Test (BPT)

NCT02403609

Sponsor

Lumos Labs, Inc.

Status

Completed

Last Update Posted

Mar 3, 2016Estimated

Enrollment

1,357Actual

Phase

Not Applicable

Conditions

Healthy Volunteers

Interventions

BPT, Computerized Assessment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Mar 26, 2015

First Submission Date that Met QC Criteria

Mar 30, 2015

First Posted Date

Mar 31, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2016

Last Update Posted Date

Mar 3, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate test-retest reliability of each subtest (correlation coefficients for Time 1 and 2) in the Brain Performance Test (BPT, Lumos Labs, Inc.).

Detailed Description

This is an open-label, randomized online study in which participants will be invited to take versions of the Brain Performance Test (BPT) on two consecutive days.

In parallel, all current Lumosity subscribers are invited to take the BPT at the beginning of their premium Lumosity experience and again every 10 weeks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,357Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BPT, Computerized Assessment	Experimental	Participants will first take the Brain Performance Test (BPT) on two consecutive days	Other: BPT, Computerized Assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BPT, Computerized Assessment	Other		BPT, Computerized Assessment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation coefficients (Pearson's r)	Correlation coefficients (Pearson's r) of scaled scores of BPT subtests at Time 1 compared to Time 2	2 days

Secondary Outcomes

Measure	Description	Time Frame
Intercorrelation coefficients (Pearson's r)	Intercorrelation coefficients (Pearson's r) of scaled scores of BPT subtests at Time 1	1 day
Principle component analysis	Principle component analysis of scaled scores of BPT subtests at Time 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Electronically signed informed consent
English-speaker
Current Lumosity free user (test-retest portion) OR current Lumosity subscriber (longitudinal portion)

Exclusion Criteria:

Visual or physical impairment that impedes computer use or completion
Under 18 years of age

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Glenn Morrison, PhD	Lumos Labs, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lumos Labs, Inc.		San Francisco	California	94105	United States

References Module

Citations

Not provided