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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03699514
• Other study ID #: ELM-52
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: January 1, 2023

Study information

• Verified date: December 2019
• Source: ElMindA Ltd
• Contact: Liran Korine
• Phone: +972-9-9516476
• Email: Liran[@]elminda.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 99 Years

Eligibility

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:

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Healthy
• Nervous System Diseases
• Neurological Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Collaborative Behavioral Health, LLC	Chicago	Illinois
United States	Kadima Neuopsychiatry Institute	La Jolla	California
United States	Alivation Health, LLC	Lincoln	Nebraska
United States	Collaborative Behavioral Health, LLC	Skokie	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
ElMindA Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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