HealthyNCT03699514
Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) Technology
An observational study of Healthy and Cognitive Impairment, run by ElMindA Ltd at 4 sites in United States.
Trial summary
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, and may be used in future regulatory submissions. Read more about this study
- Who is it for?
- Ages 8 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Cognitive Impairment, Neurological Disorder
- What is being tested?
- Brain Network Activation (BNA™) technology
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 May 2018to 1 Jan 2023
- 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 or will complete a BNA test with the Auditory Oddball Task, from both genders, aged 8-99 years.
Who may be able to join
- Completed or will complete a BNA test
- 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
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 2 recruiting
- Recruiting
Collaborative Behavioral Health, LLC
Chicago, Illinois, 60612
Ian Mackey, M.S., P.A.-C
- Completed
Kadima Neuopsychiatry Institute
La Jolla, California, 92037
- Completed
Alivation Health, LLC
Lincoln, Nebraska, 68526
- Recruiting
Collaborative Behavioral Health, LLC
Skokie, Illinois, 60076
Ian Mackey, M.S.,P.A.-C.
About this study
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, and may be used in future regulatory submissions.
Read the detailed description
A multi-center study in which subjects that had completed or are completing a BNA test with the Auditory Oddball task (or other tests that will be commercially cleared at any given time), will have the option to complete additional investigational tasks and optional clinical assessments and questionnaire forms. At each site, these additional assessments will be suggested by the site's study doctor or clinician and will be collected with the site's ePRO device. The study will include up to 10,000 subjects which had completed or will complete a standard BNA test. Authorized personnel will offer the subjects to participate in the study immediately after testing or contacting subjects that had completed the test in the past. Procedure of consent will be performed by the PI or delegates.
- Conditions
- Healthy, Cognitive Impairment, Neurological Disorder
- Being tested
- Brain Network Activation (BNA™) technology
- Keywords
- Brain Network Activation (BNA™), EEG, Cognitive Tasks
- Medical subject headings
- Cognitive Dysfunction, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Network Activation (BNA™) technologyDevice
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'). This device is indicated for use in individuals 14 to 24 years of age. The BNA Analysis System is to be used with the auditory oddball task only.
| Study group | Role | What they receive |
|---|---|---|
| Subject who completed or will complete a BNA test | Not described Receives: Device: Brain Network Activation (BNA™) technology |
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, and may be used in future regulatory submissions.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 May 2018
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ElMindA Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699514
- Sponsor's protocol ID
- ELM-52
- Status last verified
- Dec 2019
- First submitted
- 5 Oct 2018
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) Technology
- ClinicalTrials.gov ID
- NCT03699514
- Acronym / sponsor ID
- ELM-52
- Conditions
- Healthy, Cognitive Impairment, Neurological Disorder
- Keywords
- Brain Network Activation (BNA™), EEG, Cognitive Tasks
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 9 Oct 2018 (actual)
- 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 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, and may be used in future regulatory submissions.
Detailed description
A multi-center study in which subjects that had completed or are completing a BNA test with the Auditory Oddball task (or other tests that will be commercially cleared at any given time), will have the option to complete additional investigational tasks and optional clinical assessments and questionnaire forms. At each site, these additional assessments will be suggested by the site's study doctor or clinician and will be collected with the site's ePRO device. The study will include up to 10,000 subjects which had completed or will complete a standard BNA test. Authorized personnel will offer the subjects to participate in the study immediately after testing or contacting subjects that had completed the test in the past. Procedure of consent will be performed by the PI or delegates.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject who completed or will complete a BNA test | – | Device: Brain Network Activation (BNA™) technology |
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who completed or will complete a BNA test with the Auditory Oddball Task, from both genders, aged 8-99 years.
Key inclusion criteria (3 listed)
- Completed or will complete a BNA test
- 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 (0 listed)
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 |
|---|---|---|
| Brain Network Activation (BNA™) technologyThe 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'). This device is indicated for use in individuals 14 to 24 years of age. The BNA Analysis System is to be used with the auditory oddball task only. | Device | Subject who completed or will complete a BNA test |
Primary outcome
Engineering development according to clinical assessments
Time frame: 5 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, and may be used in future regulatory submissions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Cognitive Impairment, run by ElMindA Ltd at 4 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 0 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: status not confirmed, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liran Korine (+972-9-9516476, Liran@elminda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engineering development according to clinical assessments (time frame: 5 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 3 Dec 2019; AzTrials last refreshed its copy on 31 Oct 2026.