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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy; Cognitive Impairment; Neurological Disorder
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Completed
      • Kadima Neuopsychiatry Institute
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Collaborative Behavioral Health, LLC
      • Principal Investigator: Ian Mackey, M.S., P.A.-C
    • Skokie, Illinois, United States, 60076
      • Recruiting
      • Collaborative Behavioral Health, LLC
      • Principal Investigator: Ian Mackey, M.S.,P.A.-C.
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Completed
      • Alivation Health, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 99 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who completed or will complete a BNA test with the Auditory Oddball Task, from both genders, aged 8-99 years.

Description

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:

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ElMindA Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2018
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (ACTUAL): October 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 3, 2019
• Last Update Submitted That Met QC Criteria: December 2, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: EEG; Cognitive Tasks; Brain Network Activation (BNA™)
• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: ELM-52

Drug and device information, study documents

• 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