NCT02367300

Brief Summary

A prospective, non-randomized trial to validate the database of brain electrical activity recordings and clinical information collected from patients who present to the ED following closed head injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
981

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

10 months

First QC Date

February 12, 2015

Last Update Submit

June 17, 2016

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this study is to validate the clinical utility of the BrainScope Ahead 300 device for the acute identification of structural brain injuries in the TBI population, following closed head injury.

    The co-primary endpoints for this study are the sensitivity/specificity pair for CT+ identified by the Ahead 300 algorithm classification.

    30 days

Secondary Outcomes (2)

  • To demonstrate the utility of the EEG normality indicator (NI) score from a given subject presented as a percentile of the normal population and an indicator score.

    30 days

  • To evaluate the utility of creating a three-tier system for CT+ (CT-, Equivocal Zone (require close observation), and CT+).

    30 days

Interventions

BrainScope Ahead 200DEVICE

A single-use, proprietary headset containing pre-gelled electrodes will be placed on the subject's forehead according to the standard locations of the modified International 10/20 system. Subjects will undergo approximately 5 minutes of eyes closed brain electrical activity recording.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who are suspected of a traumatic, closed head injury within 72 hours will be recruited from patients who enter the Emergency Department at hospitals that are participating as clinical sites for this study.

You may qualify if:

  • Subjects who are admitted to the ED and are suspected of a traumatic, closed head injury within 72 hours. The patient will have a GCS 12-15 upon arrival to the ED even if GCS was lower prior to arrival to the ED (e.g., at the time of injury).

You may not qualify if:

  • Subjects will be excluded who have forehead, scalp, or skull abnormalities or other conditions that would prevent correct application of the electrode headset on the skin.
  • In addition,
  • subjects with dementia,
  • Parkinson's Disease,
  • multiple sclerosis,
  • seizure disorder,
  • brain tumors,
  • history of brain surgery,
  • evidence of acute psychosis,
  • substance dependence,
  • history of TIA or stroke within the last year,
  • currently receiving dialysis or in end-stage renal disease,
  • active fever defined as greater than 100 degrees F or 37.7 degrees C,
  • current condition is "critical" in the opinion of the investigator,
  • subject is suffering from an open head injury,
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Emory University- Grady Hospital

Atlanta, Georgia, 30303, United States

Location

R Cowley Shock Trauma Hospital

Baltimore, Maryland, 21201, United States

Location

Wayne State University - Detroit Receiving Hospital

Detroit, Michigan, 48235, United States

Location

Wayne State University - Sinai Grace Hospital

Detroit, Michigan, 48235, United States

Location

Washington University - Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

UT-Houston Health Science Center

Houston, Texas, 77030, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Related Publications (12)

  • Huff JS, Jahar S. Differences in interpretation of cranial computed tomography in ED traumatic brain injury patients by expert neuroradiologists. Am J Emerg Med. 2014 Jun;32(6):606-8. doi: 10.1016/j.ajem.2014.03.010. Epub 2014 Mar 18.

    PMID: 24731934BACKGROUND

  • O'Neil B, Naunheim R, DeLorenzo R. CT positive brain injury in mild TBI patients presenting with normal SAC scores. Mil Med. 2014 Nov;179(11):1250-3. doi: 10.7205/MILMED-D-13-00585.

    PMID: 25373049BACKGROUND

  • Prichep LS, Jacquin A, Filipenko J, Dastidar SG, Zabele S, Vodencarevic A, Rothman NS. Classification of traumatic brain injury severity using informed data reduction in a series of binary classifier algorithms. IEEE Trans Neural Syst Rehabil Eng. 2012 Nov;20(6):806-22. doi: 10.1109/TNSRE.2012.2206609. Epub 2012 Jul 26.

    PMID: 22855231BACKGROUND

  • Prichep LS, Ghosh Dastidar S, Jacquin A, Koppes W, Miller J, Radman T, O'Neil B, Naunheim R, Huff JS. Classification algorithms for the identification of structural injury in TBI using brain electrical activity. Comput Biol Med. 2014 Oct;53:125-33. doi: 10.1016/j.compbiomed.2014.07.011. Epub 2014 Aug 1.

    PMID: 25137412BACKGROUND

  • Naunheim RS, Treaster M, English J, Casner T. Automated electroencephalogram identifies abnormalities in the ED. Am J Emerg Med. 2011 Oct;29(8):845-8. doi: 10.1016/j.ajem.2010.03.010. Epub 2010 May 1.

    PMID: 20825903RESULT

  • O'Neil B, Prichep LS, Naunheim R, Chabot R. Quantitative brain electrical activity in the initial screening of mild traumatic brain injuries. West J Emerg Med. 2012 Nov;13(5):394-400. doi: 10.5811/westjem.2011.12.6815.

    PMID: 23359586RESULT

  • Naunheim RS, Treaster M, English J, Casner T, Chabot R. Use of brain electrical activity to quantify traumatic brain injury in the emergency department. Brain Inj. 2010;24(11):1324-9. doi: 10.3109/02699052.2010.506862.

    PMID: 20722504RESULT

  • Hanley DF, Chabot R, Mould WA, Morgan T, Naunheim R, Sheth KN, Chiang W, Prichep LS. Use of brain electrical activity for the identification of hematomas in mild traumatic brain injury. J Neurotrauma. 2013 Dec 15;30(24):2051-6. doi: 10.1089/neu.2013.3062. Epub 2013 Nov 23.

    PMID: 24040943RESULT

  • Prichep LS, Naunheim R, Bazarian J, Mould WA, Hanley D. Identification of hematomas in mild traumatic brain injury using an index of quantitative brain electrical activity. J Neurotrauma. 2015 Jan 1;32(1):17-22. doi: 10.1089/neu.2014.3365.

    PMID: 25054838RESULT

  • Ayaz SI, Thomas C, Kulek A, Tolomello R, Mika V, Robinson D, Medado P, Pearson C, Prichep LS, O'Neil BJ. Comparison of quantitative EEG to current clinical decision rules for head CT use in acute mild traumatic brain injury in the ED. Am J Emerg Med. 2015 Apr;33(4):493-6. doi: 10.1016/j.ajem.2014.11.015. Epub 2014 Nov 20.

    PMID: 25727167RESULT

  • Hanley D, Prichep LS, Badjatia N, Bazarian J, Chiacchierini R, Curley KC, Garrett J, Jones E, Naunheim R, O'Neil B, O'Neill J, Wright DW, Huff JS. A Brain Electrical Activity Electroencephalographic-Based Biomarker of Functional Impairment in Traumatic Brain Injury: A Multi-Site Validation Trial. J Neurotrauma. 2018 Jan 1;35(1):41-47. doi: 10.1089/neu.2017.5004. Epub 2017 Sep 21.

    PMID: 28599608DERIVED

  • Hanley D, Prichep LS, Bazarian J, Huff JS, Naunheim R, Garrett J, Jones EB, Wright DW, O'Neill J, Badjatia N, Gandhi D, Curley KC, Chiacchierini R, O'Neil B, Hack DC. Emergency Department Triage of Traumatic Head Injury Using a Brain Electrical Activity Biomarker: A Multisite Prospective Observational Validation Trial. Acad Emerg Med. 2017 May;24(5):617-627. doi: 10.1111/acem.13175. Epub 2017 Mar 31.

    PMID: 28177169DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Douglas C Oberly

    BrainScope Company, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2015

First Posted

February 20, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

June 21, 2016

Record last verified: 2016-06

Locations

US(11)