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

Lumos Labs

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: NP; Other: BPT

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02518204

LL001

Details and patient eligibility

About

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).

Full 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).

Enrollment: 229 patients

Sex: All

Ages: 70 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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229 participants in 2 patient groups

BPT, NP

Experimental group

Description:

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

Treatment:

Other: BPT

Other: NP

NP, BPT

Experimental group

Description:

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

Treatment:

Other: BPT

Other: NP