Clinical trial NCT02518204: Validity of an Online Neurocognitive Test Battery, the Brain Performance Test (BPT), in Normal Healthy Adults
Official title: Validity of an Online Neurocognitive Test Battery, the Brain Performance Test (BPT), in Normal Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: cognitive assessment
neuropsychological assessment
Brain Performance Test
computerized assessment
Lead sponsor: Lumos Labs, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Collaborative Neuroscience Network
First posted: 2015-08-07
Enrollment: 229
Sex: ALL
Minimum age (years): 70
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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).

Eligibility criteria: 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

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
timeFrame: 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
timeFrame: 1 day
measure: Correlation coefficients (Pearson's r and ICC) of raw scores of BPT subtests compared to raw scores of their NP correlates at Time 1
timeFrame: 1 day
measure: Correlation coefficients (Pearson's r and ICC) of BPT composite indices and NP composite indices at Time 1
timeFrame: 1 day
measure: 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
timeFrame: 2 weeks
measure: Correlation coefficients (Pearson's r and ICC) of composite indices of BPT and NP at Time 1 and Time 2 as measures of reliability
timeFrame: 2 weeks
measure: 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
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Orange County Research Center
state: California
city: Oakland
country: United States
facility: Northern California Research Center
state: California
city: Torrance
country: United States
facility: South Bay Research Center
state: California
Study officials:
affiliation: Collaborative Neuroscience Network
name: David Walling, PhD
role: PRINCIPAL_INVESTIGATOR
References: