Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) Technology

Sponsor
ElMindA Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03699514
Collaborator
(none)
10,000
4
56
2500
44.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Brain Network Activation (BNA™) technology

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

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) Technology
Actual Study Start Date :
May 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Subject who completed or will complete a BNA test

Device: Brain Network Activation (BNA™) technology
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.

Outcome Measures

Primary Outcome Measures

  1. Engineering development according to clinical assessments [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kadima Neuopsychiatry Institute La Jolla California United States 92037
2 Collaborative Behavioral Health, LLC Chicago Illinois United States 60612
3 Collaborative Behavioral Health, LLC Skokie Illinois United States 60076
4 Alivation Health, LLC Lincoln Nebraska United States 68526

Sponsors and Collaborators

  • ElMindA Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ElMindA Ltd
ClinicalTrials.gov Identifier:
NCT03699514
Other Study ID Numbers:
  • ELM-52
First Posted:
Oct 9, 2018
Last Update Posted:
Dec 3, 2019
Last Verified:
Dec 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by ElMindA Ltd
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2019