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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: BPT
* Other: NP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BPT, NP<br>Computerized assessment battery, followed by a 10 minute break, followed by conventional in-person neuropsychological assessments | Other: BPT<br>* Brain Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.<br>Other: NP<br>* 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<br>|
| Experimental: NP, BPT<br>Conventional in-person neuropsychological assessments, followed by a 10 minute break, followed by a computerized assessment battery | Other: BPT<br>* Brain Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.<br>Other: NP<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive assessment, neuropsychological assessment, Brain Performance Test, computerized assessment