Cognitive Impairment, Healthy, Neurological Disorder
Conditions
Keywords
Brain Network Activation (BNA™), EEG, Cognitive Tasks
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.
Interventions
DEVICEBrain 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.
Sponsors
ElMindA Ltd
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactLiran Korine
Outcome results
None listed