SBIR-STTR Award

Introduction. Parkinson's Disease (PD) is a common neurodegenerative disorder that a ects 1 million Americansand 10 million individuals worldwide. The incidence of PD increases with age, and men are 50% more likely tohave PD than women. The costs of PD are estimated to be $25 billion annually in the United States alone.One of the most debilitating and impactful symptoms of PD is Freezing of Gait (FOG).Problem to be Solved. FOG, de ned as an episodic absence or marked reduction of forward progression of thefeet despite the intention to walk, is a common motor symptoms of PD. FOG is a \mysterious phenomenon"with a pathophysiology that is not fully understood. FOG decreases quality of life and activity level, and oftenleads to loss of independence and injurious falls. Although FOG is more common in the later stages of PD, italso occurs in 26% of early-stage patients. Surgical and pharmacological treatments are often ine ective in reducing FOG symptoms; however, alternateinterventions can be more ecacious. External prompts, such as auditory, visual, or tactile cues, have been shownto help, but outcomes are generally mixed due to the individualized nature of FOG|various types of cues aremore or less e ective depending on individuals and their present circumstances.The ParkinSense System. The proposed body-worn ParkinSense system is specially designed to help PD patientsprevent FOG and resume ambulation when FOG occurs. The miniature, wireless ParkinSense instrument willbe easily attachable to existing prescription or nonprescription eyeglasses, or can be worn as a low-pro le bandunder a cap or hat. Using sophisticated on-board six degrees-of-freedom inertial sensing and real-time processingalgorithms, the ParkinSense system will automatically detect the onset of FOG and provide an individuallycalibrated and optimized combination of cues, including: auditory (including speech, music, or rhythmic beats), visual (transverse lines in the visual eld or blinking lights), and/or vibrotactile cues. In addition to the head-worn instrument, the ParkinSense system will include an optional limb-worn auxiliaryunit. The head-worn unit will provide the main sensing and multimode cueing capabilities, and the auxiliary unitwill enable supplemental sensing and cueing directly to a limb (e.g, a leg) if desired. The head-worn unit willcommunicate wirelessly with the limb-worn unit. The ParkinSense system will enable delivery of multiple types ofcues in any combination. Cueing can be provided automatically in response to a FOG event, manually (controlledby the wearer), or continuously. Cue delivery can be optimized to provide maximum ecacy, unobtrusiveness, and comfort for individual users. Further, the ParkinSense system will have the capability to adapt its cues inreal-time to match, for example, the functional step cadence of the wearer, thereby increasing ecacy. Project Narrative The objective of the proposed work is to develop the intelligent, easy-to-use, unobtrusive ParkinSense system to assist PD patients with freezing of gait symptoms by providing an optimal cueing strategy. The proposed system will improve quality of life for patients that su er from FOG by reducing both the incidence of FOG and the duration of FOG episodes through its multimodal, individualized, and adaptive smart cueing capability. The small size and unobtrusiveness of the ParkinSense system, and its ability to automatically detect FOG and provide the exact type of cues that are most e ective for that user or type of FOG, will be extremely appealing to patients compared to existing systems. Adult ; 21+ years old ; Adult Human ; adulthood ; Age ; ages ; Algorithms ; Ankle ; Regio tarsalis ; Tarsal Bone ; Tarsus ; Blinking ; eye blink ; eyeblink ; Cities ; Clinical Research ; Clinical Study ; Cues ; Cessation of life ; Death ; Diagnosis ; Pharmaceutical Preparations ; Drugs ; Medication ; Pharmaceutic Preparations ; drug/agent ; Limb structure ; Extremities ; Limbs ; Non-Trunk ; Eyeglasses ; Spectacles ; Face ; faces ; facial ; Feedback ; foot ; Freedom ; Liberty ; Freezing ; Gait ; Goals ; Hand ; Head ; Hospitalization ; Hospital Admission ; Incidence ; Intelligence ; Jaw ; Manuals ; men ; men's ; Movement Disorders ; Dyskinesia Syndromes ; Movement Disorder Syndromes ; Music ; Nursing Homes ; nursing home ; Parkinson Disease ; Paralysis Agitans ; Parkinson ; Parkinson's disease ; Parkinsons disease ; Primary Parkinsonism ; Patients ; Periodicity ; Cyclicity ; Rhythmicity ; Public Health ; Quality of life ; QOL ; Research ; Computer software ; Software ; Speech ; Substantia nigra structure ; Substantia Nigra ; Technology ; Thigh structure ; Thigh ; Thinness ; Leanness ; Time ; Tremor ; United States ; Woman ; Work ; Walking ; GTP-Binding Protein alpha Subunits, Gs ; G(s), alpha Subunit ; G(s), α Subunit ; G(s)alpha ; G(s)α ; GTP-Binding Protein α Subunits, Gs ; Gs alpha Family G-Protein ; Gsα ; Gαs ; Regulatory Ns Protein ; Stimulatory Gs G-Protein ; alpha Subunit Stimulatory GTP-Binding Protein ; alpha-Gs ; α-Gs ; Custom ; Intention ; sensor ; improved ; Chronic ; Clinical ; Phase ; Link ; Evaluation ; disability ; Bradykinesia ; Visual ; Individual ; Databases ; Data Bases ; data base ; Measurement ; Functional disorder ; Dysfunction ; Physiopathology ; pathophysiology ; lightweight ; light weight ; instrument ; Nature ; Tactile ; Auditory ; Event ; System ; Degenerative Neurologic Diseases ; Degenerative Neurologic Disorders ; Nervous System Degenerative Diseases ; Neural Degenerative Diseases ; Neural degenerative Disorders ; Neurodegenerative Diseases ; Neurologic Degenerative Conditions ; degenerative diseases of motor and sensory neurons ; degenerative neurological diseases ; neurodegenerative illness ; Neurodegenerative Disorders ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; American ; experience ; novel ; social ; Admission ; Admission activity ; DA Neuron ; Dopamine neuron ; dopaminergic neuron ; response ; Intervention Strategies ; interventional strategy ; Intervention ; Leg ; preventing ; prevent ; Address ; Symptoms ; Data ; Detection ; Motor ; Pharmacological Treatment ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Validation ; Wireless Technology ; wireless ; parkin gene/protein ; Parkin ; cost ; design ; designing ; Outcome ; Population ; Prevalence ; usability ; prototype ; commercialization ; multimodality ; multi-modality ; phase 1 study ; Phase I Study ; phase 2 study ; phase II study ; arm ; operation ; posture instability ; individual patient ; fall injury ; fall related injury ; injurious falls ; symptomatology ; disabling symptom ; debilitating symptom ; motor symptom ; Bluetooth ;

/ Introduction. Parkinson's Disease (PD) is a common neurodegenerative disorder that affects 1 million Americans and 10 million individuals worldwide. One of the most debilitating and impactful symptoms of PD is Freezing of Gait (FOG). FOG, defined as an episodic absence or marked reduction of forward progression of the feet despite the intention to walk, is a common motor symptom of PD. FOG is a "mysterious phenomenon" with a pathophysiology that is not fully understood. FOG decreases quality of life and activity level, and leads to loss of independence and injurious falls. Surgical and pharmacological treatments are often ineffective in reducing FOG; however, alternate interventions can be more efficacious. External prompts, such as auditory, visual, or tactile cues, have been shown to help, but outcomes are mixed due to the individualized nature of FOG-different cues are more or less effective depending on the individual and their present circumstances. The ParkinSense System. The body-worn ParkinSense system will help PD patients prevent FOG and resume ambulation when FOG occurs. The miniature, wireless ParkinSense instrument will be easily attachable to existing prescription or nonprescription eyeglasses, or can be worn as a low-profile band under a cap or hat. Using sophisticated on-board six degrees-of-freedom inertial sensing and online processing algorithms, the ParkinSense system will automatically detect FOG and provide an individually calibrated and optimized combination of cues, including: auditory (speech, music, or rhythmic beats), visual (transverse lines or a grid in the visual field), and/or vibrotactile cues. The ParkinSense system also includes a limb-worn unit to perform supplemental sensing and cueing directly to a leg. The ParkinSense system will enable delivery of multiple types of cues alone or in any combination. Cueing can be provided automatically in response to a FOG event, manually (controlled by the wearer), or continuously. Cue delivery (for example, the amplitude and frequency of the tactile cues) can be optimized to provide maximum efficacy, unobtrusiveness, and comfort for individual users. Further, the ParkinSense system will have the capability to adapt its cues; for instance, the cue rhythm can match the functional step cadence of the wearer in order to maximize response. The ParkinSense system will track FOG occurrence over time and the efficacy of each provided cue. These data will be used to further and continuously personalize the system for each user; ParkinSense will become more effective for an individual as it is used. Finally, ParkinSense will have a remote reporting capability that will allow clinicians to monitor their patients health status over time (e.g., activity level, FOG occurrence, and adherence to device use). Phase I Results. A ParkinSense prototype was designed, built, and evaluated by collecting data on patients with PD using a FOG-inducing protocol. The ParkinSense system algorithms were shown to detect FOG with high accuracy. A mixed-methods formative user-acceptance study demonstrated high acceptance, usability, and enthusiasm for the ParkinSense system. All Phase I objectives were achieved.

Public Health Relevance Statement:
Narrative The objective of the proposed work is to develop the intelligent, easy-to-use, unobtrusive ParkinSense system to assist PD patients with freezing of gait symptoms by providing an optimal, personalized cueing strategy. The proposed system will improve quality of life for patients that suffer from FOG by reducing both the incidence of FOG and the duration of FOG episodes through its multimodal, individualized, and adaptive smart cueing capability. The unobtrusiveness of the ParkinSense system, its wide range of cue varieties, and its ability to automatically detect FOG and provide the exact type of cues that are most effective, will be appealing, practical, and efficacious compared to existing systems. Terms: <21+ years old; Address; Adherence; Admission; Admission activity; Adult; Adult Human; Affect; Age; Algorithms; American; Auditory; Bluetooth; Calibration; Chronic; Clinical; Clinical Trials; Cognitive; Communities; Computer software; Cues; Custom; Cyclicity; Data; Degenerative Neurologic Disorders; Detection; Devices; Distress; Drugs; Dysfunction; Dyskinesia Syndromes; Emotional; Evaluation; Event; Extremities; Eyeglasses; Fear; Freedom; Freezing; Frequencies; Fright; Functional disorder; Gait; Goals; Head; Health Care Providers; Health Personnel; Health Status; Healthcare Providers; Healthcare worker; Home; Home environment; Hospital Admission; Hospitalization; Incidence; Individual; Intention; Intervention; Intervention Strategies; Laboratories; Leanness; Leg; Level of Health; Liberty; Limb structure; Limbs; Link; Manuals; Marketing; Medication; Methods; Monitor; Motor; Movement Disorder Syndromes; Movement Disorders; Music; Nature; Nervous System Degenerative Diseases; Neural Degenerative Diseases; Neural degenerative Disorders; Neurodegenerative Diseases; Neurodegenerative Disorders; Neurologic Degenerative Conditions; Newly Diagnosed; Non-Trunk; Nursing Homes; Operative Procedures; Operative Surgical Procedures; Outcome; Paralysis Agitans; Parkinson; Parkinson Disease; Patients; Periodicity; Persons; Pharmaceutical Preparations; Pharmacological Treatment; Phase; Phase I Study; Physiopathology; Population; Prevalence; Primary Parkinsonism; Protocol; Protocols documentation; Public Health; QOL; Quality of life; Reporting; Research; Research Design; Rhythmicity; SBIR; Small Business Innovation Research; Small Business Innovation Research Grant; Software; Specificity; Spectacles; Speech; Study Type; Surgical; Surgical Interventions; Surgical Procedure; Symptoms; System; Tactile; Technology; Thinness; Time; Visual; Visual Fields; Walking; Work; adulthood; ages; customs; debilitating symptom; degenerative diseases of motor and sensory neurons; degenerative neurological diseases; design; designing; disability; drug/agent; experience; eye field; fall injury; fall related injury; flexibility; flexible; foot; health care personnel; health care worker; health level; health provider; health workforce; healthcare personnel; homes; improved; injurious falls; instrument; interventional strategy; light weight; lightweight; medical personnel; motor symptom; multi-modality; multimodality; neurodegenerative illness; novel; nursing home; pathophysiology; phase 1 study; phase 2 study; phase II study; prevent; preventing; programs; prototype; randomized, clinical trials; response; social; study design; surgery; treatment provider; usability; verbal; wearable; wearable device; wearable electronics; wearable system; wearable technology; wearable tool; wearables; wireless