Neurological ObservationsBNA™NCT02860416
Additional Post Hoc Analysis and Clinical Data Collection
An observational study of Neurological Observations, run by ElMindA Ltd at 2 sites in United States.
Trial summary
The purpose of this study is to collect additional Investigational cognitive tasks and additional clinical data for subjects tested with ElMindA's Brain Network Activation (BNA™). Read more about this study
- Who is it for?
- Ages 8 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurological Observations
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2016to Oct 2018
- Phase
- Observational
- 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 8 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects who completed a BNA test with the Auditory Oddball Task, from both genders, aged 3-99 years.
Who may be able to join
- Completed a BNA test in the past
- Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
- Willingness to participate
Who cannot join
- Significant Sensory deficit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ElMindA
Glenview, Illinois, 60026
Premier Psychiatric Group
Lincoln, Nebraska, 68526
About this study
Official title: Additional Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) Technology
The purpose of this study is to collect additional Investigational cognitive tasks and additional clinical data for subjects tested with ElMindA's Brain Network Activation (BNA™).
Read the detailed description
To collect additional Investigational cognitive tasks and additional clinical data for subjects tested with ElMindA's Brain Network Activation (BNA™).
The BNA™ technology was developed and is utilized by ElMindA Ltd. The (BNA™) Analysis System is cleared for use by qualified medical professionals for the post hoc statistical analysis of the human electroencephalogram ("EEG"), utilizing evoked response potentials ("ERP').
- Conditions
- Neurological Observations
- Keywords
- Neurology
- Medical subject headings
- Neurologic Manifestations
What is being measured
The primary outcome is the main question the study is designed to answer.
engineering development according to clinical assessments
The study is designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical assessments and BNA scores. The results are primarily intended for scientific inquiry and engineering development purposes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological ObservationsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElMindA Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Skopin, PhD, Principal investigator, ElMindA Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860416
- Sponsor's protocol ID
- ELM-28
- Acronym
- BNA™
- Status last verified
- Jun 2019
- First submitted
- 1 Aug 2016
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) Technology
- ClinicalTrials.gov ID
- NCT02860416
- Acronym / sponsor ID
- BNA™ / ELM-28
- Conditions
- Neurological Observations
- Keywords
- Neurology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Sep 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 9 Aug 2016 (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 collect additional Investigational cognitive tasks and additional clinical data for subjects tested with ElMindA's Brain Network Activation (BNA™).
Detailed description
To collect additional Investigational cognitive tasks and additional clinical data for subjects tested with ElMindA's Brain Network Activation (BNA™).
The BNA™ technology was developed and is utilized by ElMindA Ltd. The (BNA™) Analysis System is cleared for use by qualified medical professionals for the post hoc statistical analysis of the human electroencephalogram ("EEG"), utilizing evoked response potentials ("ERP').
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who completed a BNA test with the Auditory Oddball Task, from both genders, aged 3-99 years.
Key inclusion criteria (3 listed)
- Completed a BNA test in the past
- Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
- Willingness to participate
Key exclusion criteria (1 listed)
- Significant Sensory deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
engineering development according to clinical assessments
Time frame: 2 years
The study is designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical assessments and BNA scores. The results are primarily intended for scientific inquiry and engineering development purposes.
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 6 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Mark Skopin, PhD principal investigator
ElMindA Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Observations, run by ElMindA Ltd at 2 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 3 inclusion and 1 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 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
engineering development according to clinical assessments (time frame: 2 years). 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 6 Jun 2019.