Healthy VolunteersNCT02518204
Validity of an Online Neurocognitive Test Battery, the Brain Performance Test (BPT), in Normal Healthy Adults
A study testing BPT and NP in people with Healthy Volunteers, run by Lumos Labs, Inc. at 3 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 70 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BPT and NP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2015to 28 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Orange County Research Center
Garden Grove, California, 92845
Northern California Research Center
Oakland, California, 94612
South Bay Research Center
Torrance, California, 90502
About this study
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).
Read the 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
- Being tested
- BPT, NP
- Keywords
- cognitive assessment, neuropsychological assessment, Brain Performance Test, computerized assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPTOther
Brain Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.
NPOther
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
| Study group | Role | What they receive |
|---|---|---|
| BPT, NP | Experimental | Computerized assessment battery, followed by a 10 minute break, followed by conventional in-person neuropsychological assessments Receives: Other: BPT; Other: NP |
| NP, BPT | Experimental | Conventional in-person neuropsychological assessments, followed by a 10 minute break, followed by a computerized assessment battery Receives: Other: BPT; Other: NP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficients (Pearson's r) of scaled scores of BPT subtests compared to scaled scores of their NP correlates at Time 1
Measured: 1 day
Secondary outcomes (6)
Interclass correlations (ICC) of scaled scores of BPT subtests compared to scaled scores of their NP correlates at Time 1
Measured: 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
Measured: 1 day
Correlation coefficients (Pearson's r and ICC) of BPT composite indices and NP composite indices at Time 1
Measured: 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
Measured: 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
Measured: 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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startJul 2015
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumos Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Collaborative Neuroscience Network
- Responsible party
- Sponsor
- Investigators
- David Walling, PhD, Principal investigator, Collaborative Neuroscience Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518204
- Sponsor's protocol ID
- LL001
- Status last verified
- May 2017
- First submitted
- 4 Aug 2015
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of an Online Neurocognitive Test Battery, the Brain Performance Test (BPT), in Normal Healthy Adults
- ClinicalTrials.gov ID
- NCT02518204
- Acronym / sponsor ID
- LL001
- Conditions
- Healthy Volunteers
- Keywords
- cognitive assessment, neuropsychological assessment, Brain Performance Test, computerized assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Lumos Labs, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Collaborative Neuroscience Network
- Study start
- Jul 2015
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPT, NP | Experimental | Other: BPT, Other: NPComputerized assessment battery, followed by a 10 minute break, followed by conventional in-person neuropsychological assessments |
| NP, BPT | Experimental | Other: BPT, Other: NPConventional in-person neuropsychological assessments, followed by a 10 minute break, followed by a computerized assessment battery |
Who may qualify
- Ages
- 70 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPTBrain Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc. | Other | BPT, NP, NP, BPT |
| NPConventional 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 | Other | BPT, NP, NP, BPT |
Primary outcome
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
6 secondary outcomes
Interclass correlations (ICC) of scaled scores of BPT subtests compared to scaled scores of their NP correlates at Time 1
Time frame: 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
Time frame: 1 day
Correlation coefficients (Pearson's r and ICC) of BPT composite indices and NP composite indices at Time 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Walling, PhD principal investigator
Collaborative Neuroscience Network
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BPT and NP in people with Healthy Volunteers, run by Lumos Labs, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.