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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518204
• Other study ID #: LL001
• Status: Completed
• Phase: N/A
• First received: August 4, 2015
• Last updated: May 23, 2017
• Start date: July 2015
• Est. completion date: February 28, 2017

Study information

• Verified date: May 2017
• Source: Lumos Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United States	Orange County Research Center	Garden Grove	California
United States	Northern California Research Center	Oakland	California
United States	South Bay Research Center	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Lumos Labs, Inc.	Collaborative Neuroscience Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Interclass correlations (ICC) of scaled scores of BPT subtests compared to scaled scores of their NP correlates at Time 1		1 day
Secondary	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
Secondary	Correlation coefficients (Pearson's r and ICC) of BPT composite indices and NP composite indices at Time 1		1 day
Secondary	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
Secondary	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
Secondary	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

External Links

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