Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) Technology
NCT03699514 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10000
Last updated 2019-12-03
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.
Conditions
- Healthy
- Cognitive Impairment
- Neurological Disorder
Interventions
- 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.
Sponsors & Collaborators
-
ElMindA Ltd
lead INDUSTRY
Eligibility
- Min Age
- 8 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-05-01
- Primary Completion
- 2023-01-01
- Completion
- 2023-01-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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