SBIR-STTR Award

Glaucoma is a leading cause of irreversible blindness and disability. The disease can remain relatively asymptomatic until the late stages; therefore, early detection and monitoring of vision damage is paramount to prevent functional impairment and blindness. Detection of functional visual loss in the disease has traditionally been made using standard automated perimetry (SAP). However, SAP testing is limited by the cost and complexity of its procedure, the subjectivity of patient responses, the large variability among subsequent tests, and the lack of portability of the equipment. The overall goal of this proposal is to address the limitation of currently available techniques by developing a portable objective method for the assessment of visual field loss in glaucoma. The founders of NGoggle Inc. have demonstrated that the use of multi- focal steady-state visual evoked potentials (mfSSVEPs) provides a simpler, more consistent and objective way to assess visual system integrity. Compared to the existing technologies, mfSSVEP-based perimetry will be simpler to perform, faster in producing the results and perhaps more accurate in the diagnosis due to better signal-to-noise ratios (SNRs) of its acquired data. In this Phase I SBIR project, we will leverage the founder’s discoveries and innovations to develop the NeuroGoggle, a portable objective method for assessing human functional visual field loss. The NeuroGoggle assesses patient’s visual function based on his/her mfSSVEP responses that is evoked by a constellation of multi-frequency multi-focal visual stimuli presented by a head-mounted display and recorded using a wireless EEG acquisition system. This project has the Specific Aim: To develop a wearable objective high-precision mfSSVEP-based visual field assessment prototype system, which will be comfortable to wear, easy to operate and capable of acquiring high-SNR EEG/EOG signals robustly in real-world environments. Successful development of the NeuroGoggle will provide a much-needed device that will enable patients to administer visual function tests quickly and easily at home by themselves or with the help of a companion. This will hence reduce the required number of office visits and lighten the economic and emotional burden of the disease.

Public Health Relevance Statement:
PROJECT NARRATIVE NGoggle Inc. is developing a new device, named the NeuroGoggle, for early glaucoma detection and progression monitoring. This wearable device uses a wireless electroencephalogram (EEG) acquisition system and a head-mounted display to perform objective assessment of patient’s functional visual field loss. By analyzing a specific EEG response of the patient, known as multi-focal steady-state visual evoked potentials (mfSSVEP), towards multi-frequency flickering light patterns, NeuroGoggle will enable objective evaluation of visual field deficits beyond clinical environments, improve the efficiency in diagnosing glaucoma and monitoring its progression and thus reducing the chance of visual impairment or blindness caused by the disease.

Project Terms:
Address; Anatomy; Area; Augmented Reality; Benchmarking; Blindness; Blinking; Brain; burden of illness; Cellular Phone; Clinical; commercialization; Companions; computer network; Computers; Conduct Clinical Trials; cost; Custom; Data; data acquisition; Data Analytics; Detection; Development; Devices; Diagnosis; Diagnostic; disability; Disease; Disease Progression; Early Diagnosis; Economics; electrical potential; Electrodes; Electroencephalogram; Electroencephalography; Electronics; Electrooculogram; Electrophysiology (science); Emotional; Engineering; Ensure; Environment; Equipment; Evaluation; experimental study; Eye; Eye Movements; Frequencies; functional disability; Gel; Generations; Glaucoma; Goals; Head; Home environment; Human; human subject; improved; Individual; innovation; Institutes; Life; Light; Maps; Measurement; Measures; Methods; miniaturize; Modality; Monitor; Mono-S; multidisciplinary; Muscle Contraction; Names; Nature; Noise; novel strategies; Office Visits; Patients; Pattern; Pensions; Perimetry; Peripheral; Phase; portability; pressure; prevent; Procedures; programs; prototype; quality assurance; Quick Test for Liver Function; relating to nervous system; Research; research and development; response; Retina; Retinal; Sampling; Scalp structure; sensor; Signal Transduction; Small Business Innovation Research Grant; Statistical Data Interpretation; Stimulus; System; Tactile; Techniques; Technology; Testing; Time; usability; virtual; Vision; Visual Cortex; Visual evoked cortical potential; Visual Fields; Visual impairment; visual stimulus; Visual system structure; Wireless Technology

Assessment of loss of visual function outside the foveal area is an essential component of the management of numerous conditions, including glaucoma, retinal and neurological disorders. Despite the significant progress achieved with the development of standard automated perimetry (SAP) many decades ago, assessment of visual field loss with SAP still has significant drawbacks. SAP testing is limited by subjectivity of patient responses and high test-retest variability, frequently requiring many tests for effective detection of change over time. Moreover, as these tests are generally conducted in clinic-based settings, limited patient availability and health care resources often result in an insufficient number of tests acquired over time, with delayed diagnosis and detection of disease progression. The requirement for highly trained technicians, cost, complexity, and lack of portability of SAP also preclude its use for screening of visual field loss in underserved populations. To address shortcomings of current methods to assess visual function, we have developed the nGoggle, a wearable device that uses a head-mounted display (HMD) integrated with wireless electroencephalography (EEG), capable of objectively assessing visual field deficits using multifocal steady-state visual-evoked potentials (mfSSVEP). As part of the funded NEI SBIR Phase I, we developed the nGoggle prototype using a modified smartphone-based HMD display and non-disposable electrodes. In our Phase I studies, we conducted benchmarking tests on signal quality of EEG acquisition, developed methods for EEG data extraction and analysis, and conducted a pilot study demonstrating the ability of the device to detect visual field loss in glaucoma, a progressive neuropathy that results in characteristic damage to the optic nerve and resulting visual field defects. We also identified limitations of current existing displays and electrodes, as well as potential avenues for enhancing test reliability and improving user interface. Based on the encouraging results from Phase I and a clear delineation of the steps needed to bring the device into its final commercial product form, we now propose a series of Phase II studies. We hypothesize that optimization of nGoggle's accuracy and repeatability in detecting visual function loss can be achieved through the development of a customized head-mounted display with front-view eye/pupil tracking cameras and disposable no-prep electrodes, as well as enhancement of the visual stimulation protocol and data analytics. The specific aims of this proposal are: 1) To develop a customized head-mounted display and enhanced no-prep electrodes for improving nGoggle's ability to acquire users' mfSSVEP with high signal-to- noise ratios (SNR) in response to visual stimulation; 2) To optimize and validate mfSSVEP stimuli design and data analytics to enhance the accuracy and repeatability of assessing visual function loss with the nGoggle. 3) Complete pivotal clinical studies to support FDA approval.