Validity of an Online Neurocognitive Test Battery, the Brain Performance Test (BPT), in Normal Healthy Adults

The purpose of this study is to evaluate the concurrent validity between the Brain Performance Test (BPT) subtests and corresponding conventional in-person neuropsychological assessments (NP).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: BPT; Other: NP

Detailed Description

This will be a multi-site, randomized, counterbalanced, two-period, two-sequence, validation study of the online, unsupervised Brain Performance Test (BPT). Over the course of 14 days, participants will complete two in-clinic visits during which they will complete both the BPT and in-person neuropsychological assessments (NP).

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Garden Grove, California, United States, 92845
      • Orange County Research Center
    • Oakland, California, United States, 94612
      • Northern California Research Center
    • Torrance, California, United States, 90502
      • South Bay Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 89 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Native English speaker
• Capable and willing to provide informed consent
• Able to use a computer and mouse without assistance
• Limited (< 3 days) or no experience with Lumosity.com
• Limited (< 3 days) or no experience with other cognitive training programs (e.g., FitBrains, CogMed)
• Willing to refrain from online cognitive training during the course of the study
• No recent (<1 years) experience with either computer-based or in-person neuropsychological tests (e.g., WAIS-IV, WISC, Halstead-Reitan Battery, MATRICS, CogState, CNS Vital Signs)
• Good general health assessed via self-reported online physical questionnaire and medical history questionnaire

Exclusion Criteria:

• Illiterate or unable to understand written English sufficiently to comprehend study instructions and consent form
• Uncorrected visual impairment (beyond that required to qualify for a California Driver's License) that may impact the ability to complete assessments (self-report or determined by the clinician)
• Uncorrected auditory impairment that may impact the ability to complete assessments (self-report or determined by the clinician)
• Self-reported clinical diagnosis for primary psychiatric or neurological disorder (e.g., schizophrenia, multiple sclerosis, attention deficit hyperactivity disorder, Parkinson's disease, epilepsy)
• Self-reported history of concussion or traumatic brain injury, that is considered clinically significant in the opinion of the investigator (e.g. loss of consciousness ≤ 30 minutes)
• Self-reported diagnosis of mental retardation or pervasive developmental disorder
• Self-reported diagnosis of Mild Cognitive Impairment, Alzheimer's disease, or other dementia
• Self-reported history of sustained substance or alcohol abuse or dependence, that is considered clinically significant in the opinion of the investigator (e.g. as defined by DSM-5)
• Self-report that subject is currently taking an antipsychotic, antidepressant, anti-anxiety, or a cognitively-enhancing medication (e.g. Ritalin), or in the last 72 hours, narcotics for pain or other medications that may impact cognitive performance (e.g. sleeping medications/aides or cold/allergy medications)
• Any other significant medical condition that could impact cognitive performance or result in cognitive impairment in the opinion of the investigator
• Score <28 on the MMSE
• Positive urine test for recent substance use on either testing day
• Breath Alcohol Content of 0.01% or greater on either testing day

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BPT, NP; Computerized assessment battery, followed by a 10 minute break, followed by conventional in-person neuropsychological assessments	Other: BPT; Brain Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.; Other: NP; Conventional in-person Neuropsychological Assessments (NP) Subtests from: HRB: Halstead-Reitan Battery; MATRICS: Measurement and Treatment Research to Improve Cognition in Schizophrenia; WAIS-IV: Weschler Adult Intelligence Scale - IV
Experimental: NP, BPT; Conventional in-person neuropsychological assessments, followed by a 10 minute break, followed by a computerized assessment battery	Other: BPT; Brain Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.; Other: NP; Conventional in-person Neuropsychological Assessments (NP) Subtests from: HRB: Halstead-Reitan Battery; MATRICS: Measurement and Treatment Research to Improve Cognition in Schizophrenia; WAIS-IV: Weschler Adult Intelligence Scale - IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation coefficients (Pearson's r) of scaled scores of BPT subtests compared to scaled scores of their NP correlates at Time 1	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Interclass correlations (ICC) of scaled scores of BPT subtests compared to scaled scores of their NP correlates at Time 1	1 day
Correlation coefficients (Pearson's r and ICC) of raw scores of BPT subtests compared to raw scores of their NP correlates at Time 1	1 day
Correlation coefficients (Pearson's r and ICC) of BPT composite indices and NP composite indices at Time 1	1 day
Correlation coefficients (Pearson's r and ICC) of raw and scaled scores of BPT subtests at Time 1 and Time 2 as measures of test-retest reliability	2 weeks
Correlation coefficients (Pearson's r and ICC) of composite indices of BPT and NP at Time 1 and Time 2 as measures of reliability	2 weeks
Correlation coefficients (Pearson's r and ICC) of BPT Grand Index and NP Overall Index at Time 1 and Time 2 as measures of reliability	2 weeks

Collaborators and Investigators

• Sponsor: Lumos Labs, Inc.
• Collaborators: Collaborative Neuroscience Network
• Investigators: Principal Investigator: David Walling, PhD, Collaborative NeuroScience Network

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 4, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Actual): May 25, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: cognitive assessment; Brain Performance Test; computerized assessment; neuropsychological assessment
• Other Study ID Numbers: LL001