Overview

This trial is active, not recruiting.

Condition healthy volunteers
Treatments bpt, np
Sponsor Lumos Labs, Inc.
Collaborator Collaborative Neuroscience Network
Start date July 2015
End date June 2016
Trial size 229 participants
Trial identifier NCT02518204, LL001

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Arm
(Experimental)
Computerized assessment battery, followed by a 10 minute break, followed by conventional in-person neuropsychological assessments
bpt
Brain Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.
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)
Conventional in-person neuropsychological assessments, followed by a 10 minute break, followed by a computerized assessment battery
bpt
Brain Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.
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

Primary Outcomes

Measure
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

Measure
Interclass correlations (ICC) of scaled scores of BPT subtests compared to scaled scores of their NP correlates at Time 1
time frame: 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
time frame: 1 day
Correlation coefficients (Pearson's r and ICC) of BPT composite indices and NP composite indices at Time 1
time frame: 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
time frame: 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
time frame: 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
time frame: 2 weeks

Eligibility Criteria

Male or female participants from 70 years up to 89 years old.

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

Additional Information

Official title Validity of an Online Neurocognitive Test Battery, the Brain Performance Test (BPT), in Normal Healthy Adults
Principal investigator David Walling, PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Lumos Labs, Inc..