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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860416
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
ElMindA Ltd

Brief 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™).

Condition or disease
Neurological Observations

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').

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Additional Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) Technology
Study Start Date : July 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : October 2018



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860416


Locations
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United States, Illinois
ElMindA
Glenview, Illinois, United States, 60026
United States, Nebraska
Premier Psychiatric Group
Lincoln, Nebraska, United States, 68526
Sponsors and Collaborators
ElMindA Ltd
Investigators
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Principal Investigator: Mark Skopin, PhD ElMindA Ltd
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Responsible Party: ElMindA Ltd
ClinicalTrials.gov Identifier: NCT02860416    
Other Study ID Numbers: ELM-28
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by ElMindA Ltd:
Neurology