SBIR-STTR Award

The electroencephalogram (EEG) is a sensitive and well established tool for detecting disturbances in brain function. EEG recordings, even as brief as just a few minutes, can potentially provide useful information for patients with neurological or neuropsychiatric disorders. However, most patient care settings are not able to offer EEG services due to the lack of equipment or personnel with the required expertise. As a result, timely evaluations are not performed, at times resulting in long delays in evaluation, diagnosis, and treatment. Therefore, there is a great need to develop an EEG acqusition system that can be used in any clinical settings by any caregivers. The overall goal of this SBIR project is to develop and commercialize an EEG acqusition system so that each clinic, even in a remote location, can offer EEG service for patients who might benefit from a timely assessment of their brain function. Specifically, we propose to develop, validate, and commercialize an EEG recording and assessment system (BrainView) that is compact, inexpensive, and easy-to-use by non-EEG technicians. BrainView will consist of: (1) a 10-20 system EEG electrode cap (EEG-Now) that can be easily placed on a patient’s head by any medical caregiver, and (2) a portable, handheld EEG recording machine (CereScope™) equipped with an LCD user-interface and built-in software that analyzes EEG signals and generates an output as to whether the EEG contains an abnormal pattern. In addition, CereScope will have the capability of transmitting EEG recordings to a cloud-based server for timely expert review and interpretation. Other than its use in clinics, we envision that BrainView can also be used for preliminary assessment of brain function in various sports settings and for military battlefield use. CereScope has been fully developed and is currently undergoing multi-center clinical studies in ambulatory patients and in patients admitted to either an Epilepsy Monitoring Unit or an Intensive Care Unit (SBIR Phase IIB project supported by NINDS). Hence, the focus in this Phase I project will be on the feasibility of the EEG electrode cap, EEG-Now and to validate a newly developed EEG abnormality assessment algorithm that will be installed on CereScope to be a part of the proposed BrainView system. The specific aims of this Phase I project are: Specific Aim 1: To demonstrate that non-EEG-trained personnel at a concussion clinic or a general neurology clinic can record technically satisfactory and interpretable EEG recordings (10-15 minutes) with the proposed BrainView system. Specific Aim 2: To demonstrate that the proposed EEG assessment algorithm can identify EEGs containing abnormal slowing activities or epileptiform discharges with high sensitivity (≥ 95%) and satisfactory specificity (≥ 80%). Successful commercialization of the BrainView system will significantly increase the utility and patient population of EEG diagnosis. Other than its use in clinical settings, we envision that BrainView can also be used for preliminary assessment of brain function in various sports settings and on military battlefields.

Public Health Relevance Statement:
PROJECT NARRATIVE The diagnosis and treatment in many patients, especially those who live in remote locations, with head injury or neurological disorders are often delayed, mainly due to the lack of availability (trained personnel and equipment) for a 10-15 minutes EEG diagnosis, a non-invasive, sensitive, and well-established brain function assessment. The primary goal of this project is to test a novel EEG acquisition system that can be easily made avaiable for any patient that could benefit from an EEG diagnosis. The overall goal is to improve the diagnosis and treatment of patients suffering from neurological disorders, particularly in community hospitals where EEG trained neurologists may not be available.

NIH Spending Category:
Caregiving Research; Clinical Research; Neurosciences

Project Terms:
Algorithms; Award; Brain; Brain Concussion; caregiver education; Caregivers; Clinic; Clinical; Clinical Research; cloud based; commercialization; Community Hospitals; Computational algorithm; Computer software; Craniocerebral Trauma; Data; Databases; Detection; Development; Diagnosis; Electrodes; Electroencephalogram; Epilepsy; Equipment; Evaluation; FDA approved; Florida; Goals; Gold; Head; Health care facility; Human Resources; improved; Intensive Care Units; Logistics; Medical; Military Personnel; miniaturize; Monitor; Multi-Institutional Clinical Trial; National Institute of Neurological Disorders and Stroke; nervous system disorder; Neurologist; Neurology; neurophysiology; neuropsychiatric disorder; Neurosciences; novel; Output; Patient Care; patient population; Patients; Pattern; Performance; Phase; portability; prevent; recruit; remote location; Sample Size; Sampling; Scalp structure; Scientist; Seizures; Services; Signal Transduction; Small Business Innovation Research Grant; Specificity; Sports; success; System; Testing; Time; tool; Training; Universities; Vision;