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

NCT02367274 | Completed

• 1 other identifier: 11-Ahead
• Study Type: observational
• Target: 421
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Brain Injuries

Outcome Measures

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

  30 days

Interventions

BrainScope Ahead 200 DEVICE

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

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

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,
• 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,

Sponsors & Collaborators

• BrainScope Company, Inc.: lead

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 (10)

• 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: 24731934 BACKGROUND

• 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: 25054838 BACKGROUND

• 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: 25373049 BACKGROUND

• 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: 22855231 BACKGROUND

• 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: 25137412 BACKGROUND

• 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: 20825903 RESULT

• 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: 23359586 RESULT

• 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: 20722504 RESULT

• 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: 24040943 RESULT

• 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: 25727167 RESULT

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds 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 11, 2015
• First Posted: February 20, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: April 1, 2016
• Last Updated: April 19, 2016

Record last verified: 2015-12

Locations

US (11)