Of the 119 million patients in U.S. hospital emergency departments annually, 2-10% present with altered mental status (AMS), but the electroencephalogram (EEG) is currently not among the set of rapid, first-line tests that are used to diagnose the conditions of these patients. This is a glaring unmet need, made all the more apparent when we consider that the EEG is a non-invasive recording of electrical brain activity that is indispensable for diagnosing non-convulsive status epilepticus, which is lifethreatening and frequent among patients visiting the ED with AMS. In fact, in most hospitals, EEG is not available to ED patients at all. Commonly cited reasons for not using EEG in the ED include the scarcity and expense of equipment, long waiting times, as well as the lack of space, time, funds, and expertise needed to acquire and operate this dedicated equipment. Overcoming these and other obstacles will help make EEG a standard in the ED, which studies show can improve patient care and probably also reduce health care costs. We propose, first, to complete development of an inexpensive system to rapidly record high-quality EEG in the ED and obtain an interpretation from a neurologist that may be off-site. We will optimize our existing digital wireless 'microEEG'device for the ED. The current microEEG was originally developed for seizure detection during mass casualty events, and reliably records high-quality, artifact-free EEG in the electrically-noisy ED environment. We will combine microEEG with disposable/refurbishable electrode components to create a convenient to use EEG-kit. We will add case management software to process the EEG recordings so they may be sent to off-site neurologists for interpretation because most EDs do not have a neurologist licensed to read EEGs. Second, we will evaluate how using the EEG system impacts patient outcomes and cost of care in the AMS population in a randomized control trial on AMS patients. Finally, we will obtain FDA 510(k) approval to market the system for emergency medicine.

Public Health Relevance

As many as 10% of patients in hospital emergency departments have altered mental status (AMS). While the activity of their brains can be directly assessed by the electroencephalogram (EEG) and provide the physician with valuable information for making a rapid and accurate diagnosis of their condition, EEG and the specialists needed to interpret them are not available in most emergency departments. We propose to optimize a miniature, inexpensive EEG recording kit and create software for EEG management to provide a rapid EEG interpretation to the emergency department physician from EEG specialists that can be located elsewhere.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Program (RC3)
Project #
1RC3NS070658-01
Application #
7927260
Study Section
Special Emphasis Panel (ZRG1-ETTN-C (53))
Program Officer
Conwit, Robin
Project Start
2010-04-01
Project End
2013-03-31
Budget Start
2010-04-01
Budget End
2013-03-31
Support Year
1
Fiscal Year
2010
Total Cost
$2,949,240
Indirect Cost
Name
Bio-Signal Group Corporation
Department
Type
DUNS #
127628498
City
New York
State
NY
Country
United States
Zip Code
11203
Grant, Arthur C; Abdel-Baki, Samah G; Weedon, Jeremy et al. (2014) EEG interpretation reliability and interpreter confidence: a large single-center study. Epilepsy Behav 32:102-7
Zehtabchi, Shahriar; Abdel Baki, Samah G; Omurtag, Ahmet et al. (2014) Effect of microEEG on clinical management and outcomes of emergency department patients with altered mental status: a randomized controlled trial. Acad Emerg Med 21:283-91
Grant, Arthur C; Abdel-Baki, Samah G; Omurtag, Ahmet et al. (2014) Diagnostic accuracy of microEEG: a miniature, wireless EEG device. Epilepsy Behav 34:81-5
Zehtabchi, Shahriar; Abdel Baki, Samah G; Grant, Arthur C (2013) Electroencephalographic findings in consecutive emergency department patients with altered mental status: a preliminary report. Eur J Emerg Med 20:126-9
Zehtabchi, Shahriar; Abdel Baki, Samah G; Omurtag, Ahmet et al. (2013) Prevalence of non-convulsive seizure and other electroencephalographic abnormalities in ED patients with altered mental status. Am J Emerg Med 31:1578-82
Omurtag, Ahmet; Fenton, Andre A (2012) Assessing diagnostic tests: how to correct for the combined effects of interpretation and reference standard. PLoS One 7:e52221
Zehtabchi, Shahriar; Abdel Baki, Samah G; Malhotra, Shweta et al. (2011) Nonconvulsive seizures in patients presenting with altered mental status: an evidence-based review. Epilepsy Behav 22:139-43