Publications and White Papers about BrainScope

BrainScope has a strong foundation in evidence-based research and development, including eight research contracts with the U.S. Department of Defense. Over the past 12 years, we’ve made significant investments in R&D to support our rigorously validated technology - resulting in eight FDA clearances, two international regulatory approvals, 35 peer-reviewed clinical publications, and data from over 15,000 subject evaluations. Delivering rapid, objective patient assessment remains our top priority.

Note: Specific disclosures on this page identify proposed uses that are outside cleared indications of BrainScope. Please contact us for more complete labeling.

FDA Validation Study: Structural and Functional Brain Injury (Acute)

Hanley D, Prichep LS, Badjatia N, Bazarian J, Chiacchierini R, Curley K, Garrett J, Jones E, Naunheim R, O'Neil B, O'Neill J, Wright DW, Huff JS. A Brain Electrical Activity (EEG) Based Biomarker of Functional Impairment in Traumatic Head Injury: A Multisite Validation Trial. Journal of Neurotrauma. 2018; 35(1):41-47. DOI: 10.1089/neu.2017.5004

Naunheim R, Covassin T, Jacquin A, Hanley D, Michelson E. Using a brain electrical activity biomarker could aid in the identification of mild Traumatic Brain Injury patients. American Journal of Emergency Medicine. 2018; 36(1):142-143. DOI: 10.1016/j.ajem.2017.07.007

Hanley D, Prichep LS, Bazarian J, Huff JS, Naunheim R, Garrett J, Jones E, Wright DW, O'Neill J, Badjatia N, Gandhi D, Curley K, Chiacchierini R, O'Neil B, Hack D. Emergency Department Triage of Traumatic Head Injury Using Brain Electrical Activity Biomarkers: A Multisite Prospective Observational Validation Trial. Academic Emergency Medicine. 2017; 24(5):617-627. DOI: 10.1111/acem.13175

Hack D, Huff JS, Curley K, Naunheim R, Ghosh Dastidar S, Prichep LS. Increased Prognostic Accuracy of TBI when a Brain Electrical Activity Biomarker is Added to Loss of Consciousness (LOC). American Journal of Emergency Medicine. 2017; 35(7):949-952. DOI: doi.org/10.1016/j.ajem.2017.01.060

Huff JS, Naunheim R, Ghosh Dastidar S, Bazarian J, Michelson EW. Referrals for CT scans in mild TBI patients can be aided by the use of a brain electrical activity biomarker. American Journal of Emergency Medicine. 2017; 35(11):1777-1779. DOI: https://doi.org/10.1016/j.ajem.2017.05.027

Michelson EA, Huff S, Garrett J, Naunheim R. Triage of Mild Head-Injured Intoxicated Patients Could Be Aided by Use of an Electroencephalogram-Based Biomarker. Journal of Neuroscience Nursing. 2019; 51(2):62-66. DOI: 10.1097/JNN.0000000000000420

FDA Validation Study: Concussion Index

Bazarian J, Elbin R, Casa D, Hotz G, Neville C, Lopez R, Schnyer D, Yeargin S, Covassin T. Validation of a Machine Learning Brain Electrical Activity-Based Index to Aid in Diagnosing Concussion Among Athletes. JAMA Network Open. 2021;4(2) e2037349. doi:10.1001/jamanetworkopen.2020.37349

Jacquin AE, Bazarian JJ, Casa DJ, et al., Concussion Assessment Potentially Aided by use of an Objective Multimodal Concussion Index. J Concussion. 2021;5 1–12 http://dx.doi.org/10.1177/20597002211004333

Jacquin A, Kanakia S, Oberly D, Prichep L. A multimodal biomarker for concussion identification, prognosis and management. Computers in Biology and Medicine. 2018; 102:95-103. DOI: 10.1016/j.compbiomed.2018.09.011

Wilde EA, Goodrich-Hunsaker MJ, Ware AL, Taylor BA, Biekman BD, Hunter JV, Newman-Norlund R, Scarneo S, Casa DJ, Levin HS. Diffusion Tensor Imaging Indicators of White Matter Injury Are Correlated with a Multimodal Electroencephalography-Based Biomarker in Slow Recovering, Concussed Collegiate Athletes. Journal Neurotrauma. 2020; doi.org/10.1089/neu.2018.6365

Covassin T, McGowan AL, Bretzin AC, Anderson M, Petit KM, Savage JL, Stephenson KL, Elbin RJ, Pontifex MB. Preliminary investigation of a multimodal enhanced brain function index among high school and collegiate concussed male and female athletes. The Physician and Sportsmedicine. 2020; do: 10.1080/00913847.2020.1745717.

Clinical Practice (ED/Military)

Naunheim R, Konstantinovic Koscso M, Poirier R. Reduction in unnecessary CT scans for head injury in the emergency department using an FDA cleared device. American Journal of Emergency Medicine. 2019 Oct;37(10):1987-1988. DOI: 10.1016/j.ajem.2019.04.037

Koreerat N, Russell G. An Observation of Application of Structural Brain Injury Devices for Traumatic Brain Injury Evaluation in Austere Military Prehospital Settings. Military Medicine, Volume 186, Issue Supplement_1, January-February 2021, Pages 579–583, doi.org/10.1093/milmed/usaa397

Dara T, McCarty E, Meredith P, Mooney R, Porzio D, Zeballos A. Urgent care centers can reduce ed referrals for CT scans in mild head injury with integration of brain activity biomarker. J Urgent Care Med. 2022;16(9):37-40.

Technology Description and Explanation

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. Computers in Biology and Medicine. 2014; 53:125-133. DOI: 10.1016/j.compbiomed.2014.07.011

Prichep LS, Jacquin A, Filipenko J, Ghosh-Dastidar S, Zabele S, Vodenčarević A, Rothman NS. Classification of Traumatic Brain Injury Severity Using Informed Data Reduction in a Series of Binary Classifier Algorithms. IEEE Transactions on Neural Systems & Rehabilitation Engineering. 2012; 20(6):806-822. DOI: 10.1109/TNSRE.2012.2206609

Structural Injury Assessment Development

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. American Journal of Emergency Medicine. 2015; 33(4):493-496. DOI: doi.org/10.1016/j.ajem.2014.11.015

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. Journal of Neurotrauma. 2015; 32(1):17-22. DOI: 10.1089/neu.2014.3365

Michelson EA, Hanley D, Chabot R, Prichep LS. Identification of Acute Stroke Using Quantified Brain Electrical Activity. Academic Emergency Medicine. 2015; 22(1):67-72. doi: 10.1111/acem.12561

Hanley D, Chabot R, Mould WA, Morgan T, Naunheim R, Sheth K, Chiang W, Prichep L. Use of Brain Electrical Activity for the Identification of Hematomas in Mild Traumatic Brain Injury. Journal of Neurotrauma. 2013; 30(24):2051-2056. DOI: 10.1089/neu.2013.3062

O’Neil B, Prichep L, Naunheim R, Chabot R. Quantitative Brain Electrical Activity in the Initial Screening of Mild Traumatic Brain Injuries. Western Journal of Emergency Medicine. 2012; 13(5):394-400. DOI: 10.5811/westjem.2011.12.6815

Naunheim R, English J, Treaster M, Casner T. Automated Electroencephalogram (EEG) Identifies Abnormalities in the Emergency Department. American Journal of Emergency Medicine. 2011; 29(8):845-848. DOI: doi.org/10.1016/j.ajem.2010.03.010

Naunheim R, Casner T. Novel Method for Detecting Brain Abnormality in a Patient with Epidural Hematoma: A Case Report. American Journal of Emergency Medicine. 2010; 28(3):386.e1-2. DOI: 10.1016/j.ajem.2009.05.008

Naunheim R, English J, Treaster M, Casner T, Chabot R. Use of Brain Electrical Activity to Quantify TBI Brain Dysfunction in the ED. Brain Injury. 2010; 24(11):1324-1329. DOI: 10.3109/02699052.2010.506862

Functional Injury Assessment Development

Barr W, Prichep L, Chabot R, Powell M, McCrea M. Measuring Brain Electrical Activity to Track Recovery from Sport Related Concussion. Brain Injury. 2012; 26(1):58-66. DOI: doi.org/10.3109/02699052.2011.608216

McCrea M, Prichep L, Powell M, Chabot R, Barr W. Acute Effects and Recovery After Sports-Related Concussion: A Neurocognitive and Quantitative Brain Electrical Activity Study. Journal of Head Trauma Rehabilitation. 2010; 25(4):283-292. DOI: 10.1097/HTR.0b013e3181e67923

Brooks MA, Bazarian JJ, Prichep LS, Ghosh-Dastidar S, Talavage TM, Barr W. The Use of an Electrophysiological Brain Function Index in the Evaluation of Concussed Athletes. Journal of Head Trauma Rehabilitation. 2018; 33(1):1-6. DOI: 10.1097/HTR.0000000000000328

Prichep L, McCrea M, Barr W, Powell M, Chabot R. Time Course of Clinical and Electrophysiological Recovery After Sport-Related Concussion. Journal of Head Trauma Rehabilitation. 2013; 28(4):266-273. DOI: 10.1097/HTR.0b013e318247b54e

Evidence of Clinical Need

Michelson EA, Huff S, Loparo M, Naunheim R, Perron A, Rahm M, Smith D, Stone J, Berger A. Emergency Department Time Course for Mild Traumatic Brain Injury Workup. Western Journal of Emergency. 2018; 19(4):635-640. DOI: 10.5811/westjem.2018.5.37293

Curley KC, O’Neil BJ, Naunheim R, Wright DW. Intracranial Pathology (CT+) in Emergency Department Patients With High GCS and High Standard Assessment of Concussion (SAC) Scores. Journal of Head Trauma Rehabilitation. 2018; 33(3):E61-E66. doi: 10.1097/HTR.0000000000000355

O’Neil B, Naunheim R, DeLorenzo R. CT Positive Brain Injury in Mild TBI Patients Presenting with Normal SAC Scores. Journal of Military Medicine. 2014;

179(11):1250-1253. DOI: 10.5811/westjem.2018.5.37293

Huff S, Jahar, S. Differences in Interpretation of Cranial CT in Emergency Department TBI Patients by Expert Neuroradiologists. American Journal of Emergency Medicine. 2014; 32(6):606-608. DOI: doi.org/10.1016/j.ajem.2014.03.010

Neurocognitive Test Norming for Inclusion of Norms

Vincent AS, Bailey CM, Cowan C, Cox-Fuenzalida E, Dyche J, Gorgens KA, Krawcyzk D, Young L. Normative Data for Evaluating Mild Traumatic Brain Injury with a Handheld Neurocognitive Assessment Tool. Applied Neuropsychology: Adult. 2017; 24(6):566-576. DOI: doi.org/10.1080/23279095.2016.1213263