CClinicalTrials.gg
Sign In
CompletedNCT02367274READ-TBIUpdated Apr 19, 2016

Point-Of-Care TBI Detection System For Head Injured Patients In The Emergency Department

An observational study in Brain Injuries, sponsored by BrainScope Company, Inc.. Completed at 11 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-04-19.

Sponsored by BrainScope Company, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
421
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

Read the detailed description

The objective of this study is to test the clinical utility of the BrainScope technology for the acute identification of traumatic structural brain injury in the TBI population, following closed head injury. The data generated will serve to validate and/or refine the current algorithms to detect acute, traumatic, structural brain injury.

02

Conditions studied

  • Brain Injuries

Browse trials for

03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 421 is above the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

BrainScope Company, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects who are suspected of a traumatic, closed head injury within 24 hours will be recruited from patients who enter the Emergency Department at hospitals that are participating as clinical sites for this study.

Inclusion criteria

  • Subjects who are admitted to the ED and are suspected of a traumatic, closed head injury within 24 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).

Exclusion criteria

Exclusion Criteria:

  • 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,
    • psychiatric disorder being managed by a psychiatric healthcare professional/provider,
    • 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,
    • subject requires advanced airway management (i.e. mechanical ventilation), currently receiving procedural sedation medications.
  • Subjects below the age of 18 years, and prisoners will not be eligible for study.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
421 participants (actual)
Patient registry
No

Interventions

  • DeviceBrainScope Ahead 200

    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.

06

What researchers measure

Primary outcomes

  1. Extend and replicate a database of brain electrical activity and clinical information collected from patients who present to the ED following closed head injury

    Time frame: 30 days

07

Study locations

11 sites
  • Hartford Hospital
    Hartford, Connecticut 06102, United States
  • Emory University- Grady Hospital
    Atlanta, Georgia 30303, United States
  • R Cowley Shock Trauma Hospital
    Baltimore, Maryland 21201, United States
  • Wayne State University - Detroit Receiving Hospital
    Detroit, Michigan 48235, United States
  • Wayne State University - Sinai Grace Hospital
    Detroit, Michigan 48235, United States
  • Washington University - Barnes Jewish Hospital
    St. Louis, Missouri 63110, United States
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
  • Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
  • Baylor University Medical Center
    Dallas, Texas 75246, United States
  • UT-Houston Health Science Center
    Houston, Texas 77030, United States
  • University of Virginia Medical Center
    Charlottesville, Virginia 22908, United States
08

References and documents

Publications

  • 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. PubMed 24731934 ↗
  • 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. PubMed 25054838 ↗
  • 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. PubMed 25373049 ↗
  • 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. PubMed 22855231 ↗
  • 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. PubMed 25137412 ↗
  • 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. PubMed 20825903 ↗
  • 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. PubMed 23359586 ↗
  • 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. PubMed 20722504 ↗
  • 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. PubMed 24040943 ↗
  • 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. PubMed 25727167 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02367274
Lead sponsor
BrainScope Company, Inc.
Responsible party
Sponsor
First posted
Feb 20, 2015
Start date
Jan 2015
Primary completion
Jun 2015
Completion
Apr 2016
Last update
Apr 19, 2016

Study contacts

Douglas C Oberly
principal investigator · BrainScope Company, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Brain Injuries→

Other studies from this sponsor

BrainScope Company, Inc.

Start the discussion