Additional Post Hoc Analysis and Clinical Data Collection

Neurological Observations Clinical Trial

— BNA™  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860416
• Other study ID #: ELM-28
• Status: Completed
• Start date: July 2016
• Est. completion date: October 2018

Study information

• Verified date: June 2019
• Source: ElMindA Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect additional Investigational cognitive tasks and additional clinical data for subjects tested with ElMindA's Brain Network Activation (BNA™).

Description:

To collect additional Investigational cognitive tasks and additional clinical data for subjects tested with ElMindA's Brain Network Activation (BNA™).

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').

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 99 Years

Eligibility

Inclusion Criteria:

• Completed a BNA test in the past

• 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:

• Significant Sensory deficit

Related Conditions & MeSH terms

• Neurological Observations

Locations

Country	Name	City	State
United States	ElMindA	Glenview	Illinois
United States	Premier Psychiatric Group	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
ElMindA Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years