Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 256.04K | Year: 2011
DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess Kinesia-HS, an integrated solution to facilitate pharmaceutical development of neuroprotective interventions targeted to Parkinson's disease (PD). The systemwill include both compact patient-worn instrumentation and web-based infrastructure for home monitoring to provide significantly increased motor symptom resolution in both amplitude and time. There has been tremendous growth and active research into neuroprotective treatments designed to slow the progression PD. Treatment efficacy is judged by the rate at which patient symptoms deteriorate over time. The current standard in evaluating PD motor symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a ranking system in which clinicians must be present to provide a subjective integer score to document symptom severity. The discrete nature of the UPDRS renders it profoundly inadequate for measuring the rate of deterioration of motor symptoms in a neuroprotective drug study. These drugs target patients with early PD, when symptoms are barely noticeable. It often takes years or even decades before the discrete UPDRS can detect a significant change in the rate of decline of motor symptom severity. The primary innovations of the proposed system include utilizing DBS in a clinical study to simulate disease progression, using high speed video as the gold standard linked directly back to the UPDRS for sensitivity validation, and a standardized, web-based infrastructure to improve the efficiency of clinical drug trials. We will leverage CleveMed's previously developed Kinesia system, a compact wireless system to quantify PD motor symptoms, which includes user worn motion sensors and interactive software to automate a patient exam. In two large clinical studies, the motion sensing technology successfully demonstrated objective quantification of PD motor symptoms with high correlations to clinical UPDRS motor scores. While previously existing technology will be leveraged to speed development and increase likelihood of project success, significant novel software development, system integration, and evaluation is required for the pharmaceutical application. In order to validate the quantification of very slight changes in symptom severity, the existing algorithms for quantifying tremor and bradykinesia severities will be tested against high-speed, calibrated videos that give precise measures of hand movements. In addition to highly sensitive instrumentation for monitoring PD symptoms in the home, a primary innovation of the proposed system is the infrastructure backbone to enable the straightforward integration of Kinesia-HS outputs into standardized electronic data capture software currently used in clinical trials. This standardized platform for objective home assessments could lead to clinically significant results faster and with improved resolution compared to traditional methods, which could enable breakthrough therapies to get to market faster and lower developmental costs. PUBLIC HEALTH RELEVANCE: Pharmaceutical companies are placing great emphasis on neuroprotective agents designed to slow the progression of Parkinson's disease. The current standard for evaluating motor symptoms in response to therapyis a subjective, integer rating scale that does not provide the resolution necessary to measure the rate at which motor symptoms change during disease progression. The proposed system will include both compact patient-worn instrumentation and web-based infrastructure for home monitoring to provide significantly increased motor symptom resolution in both amplitude and time and easy integration into clinical drug trials to speed the development of PD interventions.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.69M | Year: 2011
DESCRIPTION (provided by applicant): The objective is to design, implement, and clinically assess ETSense , an adaptive, compact, portable essential tremor (ET) monitor for optimizing therapeutic interventions. ET is characterized primarily by postural and kinetic (action) tremors of the limbs, which are rated by various subjective tremor rating scales. These scales all provide a discrete, subjective symptom rating at a discrete point in time, require a clinician to visually assess the patient, and cannotcapture complex fluctuations that occur throughout the day in response to interventions. Objectively capturing ET symptoms continuously during daily activities and using adaptive algorithms to both classify tremor types and severity will help clinicians better titrate therapy to minimize symptom fluctuations and expand care to rural and underserved populations. The Phase I ETSense effort successfully used kinematic data recorded from a sensor unit placed on the finger of subjects with ET to discriminate tremor from voluntary motion associated with daily activities and objectively quantified tremor severity with scores highly correlated with clinicians' qualitative ratings, providing a standardized platform for continuous ET assessment. Tremor quantificationalgorithms were extrapolated to non-standardized tasks, suggesting that it is feasible to rate tremor continuously throughout the day during activities of daily living. The three primary innovations of the proposed system include: 1) a compact, portable, user-worn device for continuous monitoring during ADLs, 2) intelligent, adaptive algorithms to continuously classify tremor type and rate severity, and 3) web-based access to symptom response reports. The clinically deployable system will be contained in alightweight, finger-worn housing for continuous wear while patients perform everyday tasks at home or in public. A push button diary will allow the patient to indicate when medication is taken. All data will be stored in memory for subsequent analysis andreport generation detailing symptom fluctuations in response to therapeutic interventions. Adaptive algorithms developed in Phase I will be further optimized to account for voluntary motion that can create tremor false positives or mask over kinematic tremor signals. The system will shift between scoring algorithms (i.e. rest, kinetic) based on any voluntary motion detected. After data collection is complete, clinicians will use a web-interface to view patient reports. These reports will detail tremor type,severity, and fluctuations, as well as when medication was taken to aid clinicians in optimizing existing therapeutic interventions or in the research and development of novel treatment protocols. We hypothesize that the commercial ETSense system will 1)continuously quantify tremor severity throughout the day during activities of daily living, 2) improve patient outcomes with better and/or faster medication optimization, 3) decrease healthcare costs by reducing office visits, and 4) enable the testing andvalidation of novel therapeutic interventions, facilitated by high-resolution continuous home monitoring. PUBLIC HEALTH RELEVANCE: Essential tremor, characterized primarily by tremor during movement, affects approximately 4% of the population overage 40 in the United States, though exact prevalence may be much higher since up to 90% of ET patients do not seek treatment. The proposed ETSense adaptive, portable essential tremor monitor will classify tremor type and rate tremor severity continuously throughout the day while a patient performs typical activities, which should help clinicians to better prescribe treatment and aid in the development of novel therapeutic interventions.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 249.82K | Year: 2012
DESCRIPTION (provided by applicant): The objective is to design, implement, evaluate and commercialize an innovative web-based education system targeted to enhance high school curriculum by stimulating early understanding of neuroscience knowledge, imagination of neuroscience applications, and interest in neuroscience careers. The scaleable MyNeuroSci system will integrate two signal modality options including innovate instrumentation and/or simulations and web-based modules for neuroacquisition, neuroanalysis, and neurogaming. This student- centered learning tool will reinvent the way high schools can integrate neuroscience with limited overhead to promote a positive impact in neuroscience knowledge and careers. Once the global leader in science and technology, the U.S. currently lags behind other countries. Economic growth can be stimulated through education investments and the field of neuroscience greatly contributes through new medical technologies and scientific careers. However, technological advancements and new career opportunities must be bootstrapped by promoting a strong understanding and interest in neuroscience during pre-college education. For America to remain competitive, our next generation must develop critical- reasoning and problem-solving skills that can be provided by foundations in neuroscience. Simple to implement, cost efficient learning tools that can easily integrate into high school curriculum should provide a solid foundation for students to recognize neuroscience opportunities,acquire a neuroscience knowledgebase, and expand critical reasoning and problem solving skills. Furthermore, it is critical learning tools are scalable and appropriate across genders, race, and wide ranging socioeconomic conditions so all students have opportunity to engage neuroscience and contribute to careers, technology development, and economic growth. The project will integrate CleveMed's expertise in lab instrumentation, neurosignal acquisition and analysis, and web-based software with the educationexpertise of Project Lead the Way, a world leader in high school curriculum development. While previous work provides a strong foundation, this program requires significant new development and integration. New curriculum and materials must be developed topromote interest and understanding across wide ranging high school and student demographics. CleveMed's extensive neurosignal database will be organized for access from web-based simulations and a wireless acquisition system optimized for cost effective,simple implementation. Scalable learning modules will provide options for student signal recording, neurosignal simulation, integrating neurosignals in gaming applications, processing and analysis, and interpretation and reporting. A web-based software infrastructure will be implemented. Providing web- based access will minimize costs associated with software maintenance, ensure students are always using the latest tools, and allow access anywhere an Internet connection is available. Finally, educational impact studies will ensure the system enhances neuroscience knowledge acquisition and interest in neuroscience careers. PUBLIC HEALTH RELEVANCE: The objective of this Fast-Track proposal is to design, implement, evaluate and commercialize an innovative web-based education system targeted to enhance high school curriculum by stimulating early understanding of neuroscience knowledge, imagination of neuroscience applications, and interest in neuroscience careers. The scaleable MyNeuroSci system will integrate two signal modality options including innovate instrumentation and/or simulations and web-based modules for neuroacquisition, neuroanalysis, and neurogaming. This student- centered learning tool will reinvent the way high schools can integrate neuroscience with limited overhead to promote a positive impact in neuroscience knowledge and careers.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 289.96K | Year: 2012
DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess ParkinStim , a home-based, noninvasive brain polarization system used during sleep to treat Parkinson's disease (PD). While current therapeutic standards of drugintervention and deep brain stimulation (DBS) show effective treatment of PD symptoms, transcranial direct current stimulation (tDCS) is a less expensive and less invasive potential alternative/adjunct treatment with few side effects that may help treat PD symptoms, decrease medication usage, and reduce sleep disturbances. Recent studies have demonstrated that noninvasive anodal tDCS applied to the scalp over primary motor cortex (M1) can improve PD symptoms. tDCS provides polarization to the cerebral cortex via painless weak currents transmitted through noninvasive scalp electrodes. Unlike other noninvasive stimulation modalities such as transcranial electrical stimulation (TES) and rapid transcranial magnetic stimulation (rTMS) that can be painful and cause side effects including seizures and psychotic symptoms, tDCS is painless, poses few side effects, and is ideal for home use since it can be provided in an inexpensive and compact package. The primary innovations of ParkinStim include 1) easy-to-don wearable tDCS hardware suitable for home use, 2) a technique for providing tDCS during sleep, and 3) a therapeutic tDCS system to treat PD symptoms and related sleep disturbances. The proposed system will provide a wearable device that patients with PD can easily don before going to sleep and use through the night. Since patients often feel worst in the morning after medication from the previous day has worn off, stimulation during the night may help patients wake up feeling better. Additionally, designing thedevice for overnight use will make the system convenient and accessible so patients need not worry about using the device in public or during their daily activities. Development will focus on treating the motor symptoms of PD; however, the proposed systemmay prove beneficial for other PD symptoms or related sleep disturbances. For this Phase I, we aim to demonstrate 1) technical feasibility by safely and effectively using existing stimulation and electrode hardware to provide tDCS to PD patients during sleep and 2) clinical feasibility by demonstrating that tDCS reduces PD symptom severities and decreases symptom fluctuations. Ten PD subjects will participate in a counterbalanced crossover clinical study during which tDCS is applied to M1 while the subjectsleeps in a sleep laboratory and standard polysomnography data is collected. Phase I success criteria include safely and effectively administering tDCS to PD patients during sleep without causing waking and demonstrating an acute therapeutic effect of tDCS. While Phase I is designed to evaluate the acute benefits of tDCS, Phase II will investigate the chronic benefits of multiple nights of tDCS used in the home over several weeks. We hypothesize that the final system resulting from Phase I and II development will provide safe and effective tDCS during sleep, decrease PD symptom severities, minimize motor fluctuations, reduce required medication, and improve sleep quality. PUBLIC HEALTH RELEVANCE: Parkinson's disease affects nearly 1.5 million Americans with annual treatment costs approaching 25 billion. While current therapeutic standards of drug intervention and deep brain stimulation (DBS) show effective treatment of PD symptoms, transcranial direct current stimulation (tDCS) during sleep is a less expensive and less invasive potential alternative/adjunct treatment with few side effects that may help treat PD symptoms, decrease medication usage, and reduce sleep disturbances. Successful development will result in a safe, easy-to-use home-based tDCStherapy system PD patients can use during the night to feel better during the day.
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 690.96K | Year: 2015
DESCRIPTION provided by applicant The objective is to engineer build and clinically validate DBS Expert an expert system for optimizing postoperative programming of deep brain stimulation DBS in patients with movement disorders such as Parkinsonandapos s disease PD The clinical utility of DBS for treatment of PD is well established However great outcome disparity exists among recipients due to varied postoperative management particularly concerning DBS programming optimization Many programmers have only a cursory understanding of electrophysiology and lack expertise and or time required to determine an optimal set of DBS parameters from thousands of possible combinations DBS Expert will improve outcomes and equalize care across the country for patients not in close proximity to DBS specialty centers The primary innovations include automated functional mapping based on objective motion sensor based motor assessments that will intelligently navigate the DBS parameter space to guide the programming session and intelligent algorithms that will find a set of parameters that optimize for efficacy while minimizing side effects and battery usage The clinically deployable DBS Expert system will include wireless wearable motion sensors a tablet software app and secure cloud storage The app will include a simple interface to guide the programming session collect all sensor and stimulation data and adjust DBS settings For typical use the system will start by performing automated monopolar survey to determine the patient specific functional anatomy around the lead site and narrow the search space for determining an optimal set of programming parameters This therapeutic window will be valuable at the initial postoperative programming session and simplify subsequent adjustment sessions In Phase I subjects with PD wore our existing Kinesia motion sensor while prototype software guided an automated monopolar survey Stimulation was incrementally increased at each contact until symptoms stopped improving or side effects appeared Search algorithms were successfully developed to automatically identify optimal DBS stimulation parameters Parameters chosen by the algorithms improved symptoms by nearly or maintained therapeutic benefits while reducing stimulation amplitude to decrease battery usage Phase II will include developing an app to integrate the successful Phase I prototype functional mapping software with DBS IPG programmer communication protocols to streamline use a multi center clinical evaluation to optimize specific functional mapping protocols and parameter space navigation algorithms and integration of the optimal search algorithm and bidirectional communication protocols into a commercially viable product We hypothesize DBS Expert will improve patient outcomes access to care clinician and patient experience battery usage and frequency and duration of follow up programming sessions compared to traditional programming practices PUBLIC HEALTH RELEVANCE The clinical utility of deep brain stimulation DBS for the treatment of movement disorders such as Parkinsonandapos s disease has been well established however there is a great disparity in outcomes among DBS recipients due to varied postoperative management particularly concerning the choosing of an optimal set of programming parameters from the thousands of possible combinations The proposed system will use motion sensor based assessments to develop a functional map and intelligent algorithms to determine a set of programming parameters that maximize symptomatic benefits while minimizing side effects and battery consumption