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OpenTrials
Completed

NCT Number: NCT02518204

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).

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Key information

Conditions

Age range

70 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orange County Research Center, Garden Grove, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BPT

Other

Brain Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.

NP

Other

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

Primary outcomes

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

    Time frame: 1 day

Secondary outcomes

  1. Interclass correlations (ICC) of scaled scores of BPT subtests compared to scaled scores of their NP correlates at Time 1

    Time frame: 1 day

  2. Correlation coefficients (Pearson's r and ICC) of raw scores of BPT subtests compared to raw scores of their NP correlates at Time 1

    Time frame: 1 day

  3. Correlation coefficients (Pearson's r and ICC) of BPT composite indices and NP composite indices at Time 1

    Time frame: 1 day

  4. 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

    Time frame: 2 weeks

  5. Correlation coefficients (Pearson's r and ICC) of composite indices of BPT and NP at Time 1 and Time 2 as measures of reliability

    Time frame: 2 weeks

  6. 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

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Lumos Labs, Inc.

Industry

Collaborators

  • Collaborative Neuroscience Network

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 7, 2015
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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