NCT02518204CompletedNot Applicable
Validity of an Online Neurocognitive Test Battery, the Brain Performance Test (BPT), in Normal Healthy Adults
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lumos Labs, Inc.
- Enrollment
- 229
- Locations
- 6
- Primary Endpoint
- Correlation coefficients (Pearson's r) of scaled scores of BPT subtests compared to scaled scores of their NP correlates at Time 1
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 70 Years to 89 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
- 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 BPT Grand Index and NP Overall Index at Time 1 and Time 2 as measures of reliability(2 weeks)
- 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 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 composite indices of BPT and NP at Time 1 and Time 2 as measures of reliability(2 weeks)
Investigators
Study Sites (6)
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