Many patients arriving at the Intensive Care Unit (ICU) are in the state of coma due to a severe injury or disease. Among these patients, Non-Convulsive Seizures (NCS) and Non-Convulsive Status Epilepticus (NCSE) are critical neurophysiological conditions which may not have overt clinical signs. These conductions can be diagnosed only with EEG monitoring. Studies have shown that approximately 40% and 10% of the critically ill patients in the ICU have NCS and NCSE respectively. Prolonged NCS and NCSE can lead to permanent brain injury. Guidelines published by Neurocritical Care Society require EEG within 15-60 minutes after status epilepticus (SE) are suspected. Although many ICUs have been using EEG to diagnose NCS and NCSE, unfortunately, only approximately 2% of the emergency department in the US have EEG technicians available constantly, clearly underdiagnosing the problem. In addition, the time to install EEG electrodes in the standard 10-20 configuration takes about 45 minutes by a trained EEG specialist. In the emergency department, on average, it takes 3 hours to obtain and interpret an EEG. Primary reasons for this time-consuming procedure are: 1) setting up EEG equipment in busy, human resource constrained ICU is currently a complex procedure, 2) installing electrodes on the scalp of patients is time-consuming, 3) EEG leads interfere with critical care procedures, and 4) loose electrodes cause noise or interruption in data collection. As the result of these technical problems, EEG study is commonly conducted only after the patientâs condition is stabilized. This implies a miss of possibly important diagnostic information during early portions of emergency care procedures, including those at the site of injury, during patient transportation, and during initial injury management in the ICU. This miss of monitoring and diagnostic opportunities may result in serious, possibly life-threatening consequences. In order to solve these problems and comply with the unique point-of-care environment, we will develop a novel EEG acquisition device. This device is a self-contained EEG sensor in the size of a U.S. penny that is miniature, leadless and single-unit, reducing the clinical EEG practice from a complex procedure to a simple twist on the scalp. By simply pressing the EEG sensor against the unprepared scalp and twisting slightly, the device can grasp the skin firmly and start acquiring and transmitting EEG wirelessly to a bedside monitor, a smartphone, or a Bluetooth enabled device in emergency departments. Although the new EEG sensor will not replace the traditional, full-montage EEG study currently conducted at a non-emergency setting, it will allow acquisition of EEG at one or several scalp sites quickly during emergency care to assess the neurological status of patients, which has a significant diagnostic value and will save lives. Our research team includes three engineers and two medical doctors who practices in the ICU. The investigators hold three patents on a novel dry electrode which will be used as the basic structure of our proposed sensor. In this Phase 1 SBIR project, we will improve the electrode of the new EEG sensor, design electronic circuitry that can be fit within the body of the sensor, and prove the feasibility of the new sensor by conducting a validation study on human subjects. After the completion of this project, we will firmly prove the feasibility of the new leadless, single unit and penny sized EEG sensor for its further development in Phase 2 SBIR.
Public Health Relevance Statement: Narrative Many patients arriving at the Intensive Care Unit (ICU) are in the state of coma due to a severe injury or disease. Among these patients, many develop dangerous hidden seizures that can only be detected by continuous electroencephalographic (EEG) recording. However, the current EEG measurement is too time- consuming, not suitable for use in the ICU. This bioengineering project will develop a new EEG sensor to solve this clinical problem.
NIH Spending Category: Bioengineering; Brain Disorders; Clinical Research; Emergency Care; Epilepsy; Health Services; Injury (total) Accidents/Adverse Effects; Neurodegenerative; Neurosciences
Project Terms: Accident and Emergency department; Algorithms; Arousal; base; Biomedical Engineering; Blood Pressure; Bluetooth; Brain; brain computer interface; Brain Injuries; Brain Stem; Cardiac Output; Cardiopulmonary; Caring; Cellular Phone; Clinical; clinical decision-making; Collection; Coma; Comparative Study; Complex; Consumption; Critical Care; Critical Illness; Dangerousness; Data Collection; data exchange; design; Detection; Development; Devices; Diagnosis; Diagnostic; Disease; Drowsy Driving; Early identification; Early treatment; Effectiveness; electric impedance; Electrocardiogram; Electrodes; Electroencephalogram; Emergency Care; Emergency Medicine; emergency settings; Emergency Situation; Engineering; Environment; Epilepsy; Equipment; Evaluation; Failure; Gel; Gold; grasp; Guidelines; Home environment; Hour; Human Resources; human subject; improved; Injury; Intensive Care Units; Interruption; Ischemic Stroke; Knowledge; Laboratories; Lead; Legal patent; Life; Measurement; Medical; mental state; Monitor; Morbidity - disease rate; mortality; Motor; Nervous System Physiology; Nervous System Trauma; Neurologic; Neurological status; neurophysiology; Noise; Non-Convulsive Status Epilepticus; novel; off-patent; Oxygen; Painless; Paralysed; Patient Monitoring; Patients; Pharmaceutical Preparations; Phase; physical state; Physiologic Monitoring; point of care; pressure; Problem Solving; Procedures; Publishing; Reflex action; Reporting; Research; Research Personnel; Respiration; response; Scalp structure; sedative; Seizures; sensor; Signal Transduction; Site; Skin; Sleep; Small Business Innovation Research Grant; Societies; Specialist; Sports; Status Epilepticus; Stimulus; Stroke; Structure; System; Technology; Therapeutic; Time; tool; Training; Transportation of Patients; Traumatic Brain Injury; validation studies; wearable device; Wireless Technolog
