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

• Conditions: Cognitive Impairment; Healthy; Neurological Disorder
• Interventions: Device: Brain Network Activation (BNA™) technology

• Registration Number: NCT03699514
• Lead Sponsor: ElMindA Ltd

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.

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 Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-03
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subject who completed or will complete a BNA test	Brain Network Activation (BNA™) technology	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Alivation Health, LLC; 🇺🇸 Lincoln, Nebraska, United States

Collaborative Behavioral Health, LLC; 🇺🇸 Skokie, Illinois, United States

Kadima Neuopsychiatry Institute; 🇺🇸 La Jolla, California, United States