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

NCT02518204 | Completed

• 1 other identifier: LL001
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Healthy Volunteers

Keywords

cognitive assessment; neuropsychological assessment; Brain Performance Test; computerized assessment

Outcome Measures

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

  1 day

Secondary Outcomes (6)

• 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

Study Arms (2)

BPT, NP

EXPERIMENTAL

Computerized assessment battery, followed by a 10 minute break, followed by conventional in-person neuropsychological assessments

Other: BPT; Other: NP

NP, BPT

EXPERIMENTAL

Conventional in-person neuropsychological assessments, followed by a 10 minute break, followed by a computerized assessment battery

Other: BPT; Other: NP

Interventions

BPT OTHER

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

BPT, NP; NP, BPT

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

BPT, NP; NP, BPT

Eligibility Criteria

• Age: 70 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lumos Labs, Inc.: lead
• Collaborative Neuroscience Network: collaborator

Study Sites (3)

Orange County Research Center

Garden Grove, California, 92845, United States

Location

Northern California Research Center

Oakland, California, 94612, United States

Location

South Bay Research Center

Torrance, California, 90502, United States

Location

Study Officials

• David Walling, PhD

  Collaborative Neuroscience Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 7, 2015
• Study Start: July 1, 2015
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: May 25, 2017

Record last verified: 2017-05

Locations

US (3)