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

NCT ID: NCT02518204

Last Updated: 2017-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 229 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-02-28

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).

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

BPT, NP

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

Group Type: EXPERIMENTAL

BPT

Intervention Type: OTHER

Brain Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.

NP

Intervention Type: OTHER

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

NP, BPT

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

Group Type: EXPERIMENTAL

BPT

Intervention Type: OTHER

Brain Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.

NP

Intervention Type: OTHER

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

Interventions

BPT

Brain Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.

Intervention Type: OTHER

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Collaborative Neuroscience Network

UNKNOWN

Sponsor Role: collaborator

Lumos Labs, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Walling, PhD

Role: PRINCIPAL_INVESTIGATOR

Collaborative Neuroscience Network

Locations

Orange County Research Center

Garden Grove, California, United States

Northern California Research Center

Oakland, California, United States

South Bay Research Center

Torrance, California, United States

Countries

United States

Other Identifiers

LL001

Identifier Type: -

Identifier Source: org_study_id