Greenwings Biomedical, Inc. — Department of Health and Human Services SBIR Phase I: NIA

Description

PROJECT SUMMARY ABSTRACT This proposed SBIR study is for the advancement to market of a medical system that automatically and quickly measures and quantifies EEG signals to correlate with clinical staging and cognitive impairment associated with Alzheimer s DiseaseADand mild cognitive impairmentMCIThe envisioned systemdesigned to be used in emergentinpatientambulatory and research settingswill provide automaticinstant quantitative results to guide medical practitioners and researchersIt could be used as a diagnostic or monitoring tool or integrated into goal directed therapiesOur envisioned system is based on an algorithm called Multifractal Detrended Fluctuation AnalysisMF DFAof EEGThe theoretical considerations about underlying cortical neuronal activitythe experimental results obtained in distinguishing states of consciousnessand the preliminary data obtained by this study s scientific team strongly support investigating the potential of MF DFA as a diagnosis and treatment tool for AD MCIA biomarker derived from EEG signals that correlates with AD MCI s executive function deficits and associated cortical network dysfunction would be an important clinical and research toolIts advantages for both screening and follow up diagnosis and monitoring compared to current neuroimaging and neuropsychological procedures would be low costconvenience and quicknessSuch an EEG based biomarker for executive function deficits would be a major innovation for cliniciansgiven the diagnostic uncertaintyAD MCI s high prevalence and associated morbidityThe envisioned system s tests wouldimprove the accuracy of AD MCI s diagnosis and progression measurementbe capable of being used in clinical and research settings across the spectrum of caregive realtimeactionable clinical informationenable diagnostic and monitoring procedures that are less expensive than currently available proceduresandprovide physicians and researchers a tool to measure the efficacy of pharma and other therapiesPreliminary research data show that the device may also assess brain dysfunction caused by sleep disordersother dementiasand traumatic brain injuryThis proposed study is aligned with the limited purposescope and budget of SBIR Phase I studiesThe specific purpose is to obtain reasonably quickly and inexpensively andapos go no goandaposguidance to continue pursuing the development of our envisioned systemSpecificallythe study s aims are to further demonstrate what is shown by our preliminary data that MF DFA is sensitive and specific for diagnosing the cognitive and functional impairment of AD MCIA andapos goandaposstudy result would justify future studies including SBIR Phase II projectssome of which will rigorously investigate the method s specificitysensitivityrepeatability and reliabilityThis study will perform MF DFA on the EEG tracings ofde identified clinical caseseach with EEG traces and quantitative measures of depression and clinical stagingselected from a database owned by BBA HealthIncThe database contains age matched elderly individuals followed over a five year periodmany of whom developed MCI or AD during the studyThe patients underwent quarterly resting state EEGminand yearly information was collected about subjectsagedemographicsethnicitygenderyears of educationactual clinical diagnosisFolstein Mini Mental Status ExamMMSEscoresHamilton Depression Rating Scale scoresHamDand Alzheimerandapos s Disease Assessment Scale cognitive subscale scores PROJECT NARRATIVE This study is for the advancement to market of a medical device system that automatically and quickly measures and quantifies EEG signals to correlate with AD MCI s clinical staging and cognitive impairmentThe envisioned systemdesigned to be used in emergentinpatientambulatory and research settingswill provide automaticinstant quantitative results to guide medical practitioners and researchersIt could be used as a diagnostic or monitoring tool or integrated into goal directed therapies