Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) Technology
1 other identifier
observational
10,000
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 5, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedDecember 3, 2019
December 1, 2019
4.7 years
October 5, 2018
December 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
5 years
Study Arms (1)
Subject who completed or will complete a BNA test
Interventions
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.
Eligibility Criteria
Subjects who completed or will complete a BNA test with the Auditory Oddball Task, from both genders, aged 8-99 years.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ElMindA Ltdlead
Study Sites (4)
Kadima Neuopsychiatry Institute
La Jolla, California, 92037, United States
Collaborative Behavioral Health, LLC
Chicago, Illinois, 60612, United States
Collaborative Behavioral Health, LLC
Skokie, Illinois, 60076, United States
Alivation Health, LLC
Lincoln, Nebraska, 68526, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2018
First Posted
October 9, 2018
Study Start
May 1, 2018
Primary Completion
January 1, 2023
Study Completion
January 1, 2023
Last Updated
December 3, 2019
Record last verified: 2019-12