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

ElMindA

Status: Unknown

Conditions: Healthy; Cognitive Impairment; Neurological Disorder

Treatments: Device: Brain Network Activation (BNA™) technology

Study type: Observational

Funder types: Industry

Identifiers

NCT03699514

ELM-52

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 8 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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:

Trial design

10,000 participants in 1 patient group

Subject who completed or will complete a BNA test

Treatment:

Device: Brain Network Activation (BNA™) technology