Additional Post Hoc Analysis and Clinical Data Collection (BNA™)

June 5, 2019 updated by: ElMindA Ltd

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

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™).

Study Overview

Status

Completed

Conditions

Detailed 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').

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Glenview, Illinois, United States, 60026
        • ElMindA
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Premier Psychiatric Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who completed a BNA test with the Auditory Oddball Task, from both genders, aged 3-99 years.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
engineering development according to clinical assessments
Time Frame: 2 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ElMindA Ltd

Investigators

  • Principal Investigator: Mark Skopin, PhD, ElMindA Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ELM-28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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