Joseph P. Giuffrida, Ph.D. - US grants

The objective is to design, build, and clinically assess an Untethered Home Therapy System (UHTS). The research will focus on functional motor recovery in the upper extremity of stroke patients, There has currently been tremendous growth and research into motor relearning after stroke. Carefully directed, repetitive practice of skills is essential to improving recovery. The UHTS should aid in improving the time course and amount of functional recovery from upper extremity motor deficits. This unique system will employ armbands containing dry surface EMG electrodes and a small radio transmitter to transmit EMG to a nearby laptop computer. Software will instruct the patient through a series of prerecorded movies while monitoring EMG. Tasks will include a variety of arm movements, grasp force tracking, EMG tracking, and grasp strength. By monitoring EMG, the software will discriminate tasks, monitor compliance, and provide real-time user feedback. During Phase I we will design, build, and clinically evaluate the feasibility of recording upper extremity EMG with the armband telemetry system, develop algorithms for task discrimination, and a develop a prototype of the user interface software. The prototype UHTS will be clinically evaluated on five stroke subjects to ensure task discrimination, effective subject feedback, and clinical efficacy.

DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess ParkinSense", a wireless movement disorder monitor for Parkinson's disease (PD). Three major PD symptoms that affect quality of life include tremor, bradykinesia, and dyskinesias. These symptoms are often responsible for functional disability and social embarrassment. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a qualitative ranking system. Objectively quantifying PD symptoms would aid in evaluating treatment protocols. Monitoring symptoms at home would allow a clinician to capture complex fluctuation patterns in treatment response instead of only examining during an office visit or relying on patient journals. The patient worn hardware consists of small, lightweight components. A finger unit housing orthogonal accelerometers and gyroscopes measures three-dimensional motion. A wrist unit provides data acquisition, memory, power, electromyography (EMG) amplifiers, and a Bluetooth" radio for wireless data transmission. Clinical interface software collects, processes, and presents motion and EMG. During Phase II quantitative variables were processed from the data and applied to algorithms to assess severity of tremor, bradykinesia, and rigidity. The Phase II ParkinSense system showed excellent results to objectively quantify symptoms in the clinic. The main goal of this proposed Phase II continuation grant is to complete final system modifications for home use. Additionally, a large multi-center clinical trial will be designed to further validate and improve algorithms and evaluate use in patient homes. This data is critical to proving safety and effectiveness to obtain Food and Drug Administration clearance to market. First, the patient unit size and weight will be minimized. Next, the software will be significantly upgraded for home use including reporting features and improved user feedback. An infrastructure will be designed to retrieve reports remotely from patient homes. Finally, ParkinSense will be tested in a large, multi-center clinical study and in the homes of PD subjects. Data from the clinical trials will be used to further validate and improve automated detection and symptom severity rating algorithms developed during the Phase II effort. We hypothesize ParkinSense will capture symptom variables that correlate to qualitative clinician scoring and patient event marking of tremor, bradykinesia, and dyskinesias. In addition, to illustrate success ParkinSense should be successfully used at home and PD subjects should have a high level of device acceptance.

DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess an Adaptive Wireless Computer Mouse (AWCM) for movement disorders. Development will focus on Parkinson's disease (PD) and essential tremor (ET). Major symptoms of PD include tremor, dyskinesias, bradykinesia, and rigidity. ET produces tremors that affect motor function. Symptoms from these diseases have a large effect on upper extremity motor control for afflicted patients. One activity affected is using a mouse for computer cursor control. A standard computer mouse translates user hand movement to cursor position on the computer display. PD and ET symptoms create noise that can mask user intention information. Noise may be in the form of involuntary movements such as tremor or dyskinesias or in the form of difficulty in initiating movements from bradykinesia or rigidity. The specific aim of this proposal is to develop and assess an AWCM that can detect a specific movement disorder symptom and provide compensation. The proposed AWCM is a wearable computer accessory to enhance computer and Internet access for those with movement disorders. This proposed assistive device would allow individuals to maintain their sense of computer independence, remain computer proficient at work/home, and may improve their social, economic, and learning capabilities

DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess a Multimodal Pediatric Motor Recovery System, the PediAssist. Development will focus on functional motor recovery in the upper extremity of cerebral palsy (CP) patients. The PediAssist should improve the time course and amount of functional recovery from CP motor deficits. The system will utilize wearable stimulating and sensing technology to adaptively control a video game interface and provide a home-based system for continuing and monitoring therapy. A user worn game sleeve will be embedded with dry surface electromyography (EMG) recording electrodes, kinetic sensors, a stimulator unit, and a small radio transceiver. Movements, coordination patterns, and/or EMG levels will translate to clinician defined video game commands. Command thresholds and functional electrical stimulation (FES) to paralyzed muscles will be adaptively modulated based on user video game performance. Quantitative measures related to functional improvement will also be recorded and presented to clinicians. During Phase I, we hypothesize that 1) the wearable telemetry system will accurately record EMG and kinetic data and control game inputs 2) adaptive algorithms for modulating video game parameters and FES can be implemented, and 3) the system will provide effective feedback through the video game interface.

[unreadable] DESCRIPTION (provided by applicant): The objective is to develop a miniature, wireless, multi-channel, neonatal intensive care unit (NICU) & monitoring system that provides physiological and behavioral parameters. The system utilizes a small physiological monitor and isolette mounted camera. The NICU is an extremely challenging environment since patients are small, medically fragile, and surrounded by bulky equipment. Current bedside devices are large and cumbersome, which impede nursing care and inhibit clinical traffic. Continuous physiologic monitoring can provide critical data to guide diagnosis and treatment. An unobtrusive monitoring system that can be placed directly into the isolette would allow continuous monitoring while minimizing patient hazards and inconvenience. The final commercial system will provide a small, lightweight wireless system for unobtrusive NICU monitoring. Specifically during the continuing Phase II effort, we plan to upgrade the radio link, increase external sensors options, minimize cost, and ensure the system meets medical equipment quality standards. Software upgrades will improve user friendliness, integrate new tools to compare studies, and provide customizable reporting features. New algorithms will be integrated to improve utility and research flexibility. Significant verification and validation testing will ensure that all applicable standards are met. Finally a large clinical trial will be completed with neonatal subjects to ensure clinical efficacy. [unreadable] [unreadable]

[unreadable] DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess an intelligent device, the PediActive, to assist upper extremity motor control in cerebral palsy (CP). Children with hemiplegic CP often have upper extremity impairments including slowness, weakness, uncoordinated motion, and spasticity. The PediActive should enhance function by automatically complimenting a person's remaining voluntary motor control with functional electrical stimulation (FES) during activities of daily living. The PediActive should provide levels of function unachievable with only voluntary control. The user will not need to learn a new control algorithm. Instead, the user will simply attempt to complete a task. The PediActive will detect subject motion intention and automatically supply stimulation to target muscles to assist the task. The PediActive should ultimately aid CP subjects in completing activities of daily living thereby increasing independence and societal participation. While the ability to complete functional tasks can be compromised in CP, upper extremity motion and muscle activation patterns as they attempt tasks can be quite repeatable. The PediActive will take advantage of these patterns to automatically detect user intention. Therefore, the proposed PediActive will utilize wearable sensing and stimulating technology to automatically modulate FES and improve function. A user worn shirt or sleeve will be embedded with surface electromyography (EMG) electrodes, kinetic sensors, and a stimulator unit. The system will record EMG and kinetic data to determine user movement intention. Movements, coordination patterns, and/or EMG levels will then be used as inputs to train a neural network to output an appropriate level of FES to specific upper extremity muscles. Specifically, the PediActive will automatically detect when a user is attempting arm reach or hand grasp and apply FES to target muscles to assist the task. The PediActive will be an assistive device to improve upper extremity function in children with cerebral palsy. The system will be trained to automatically detect when a user is attempting a task and supply stimulation to target muscles to help the subject complete the task. The system should help subjects complete activities of daily living, thereby increasing their independence and societal participation. [unreadable] [unreadable]

[unreadable] DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess an assistive device, PediAccess", which will improve augmentative alternative communication for children with compromised speech and motor function due to cerebral palsy (CP). Speech affects education, communication with family and clinicians, and societal participation. This project will focus on children with CP who cannot speak and have compromised upper extremity motor control that impedes effective use of a standard computer for communication. Some AAC devices currently exist, but all have significant limitations. Some examples include: a simple board that requires the user to gaze at answers; a reflective forehead worn marker that uses head movement and dwell time to move a cursor and select options; a screen that continually cycles highlighted options and waits for a push button triggered by the hand or head to select the option when highlighted; and multiple choice touch screens. While these devices have shown some efficacy to improve communication, they can be slow to navigate, may not be cosmetically acceptable, struggle to maintain calibration, and do not take full advantage of potential degrees of freedom (DOF) remaining for control. Additionally, once communication is lost, a computer typically becomes the interface between cognitive speech intention and fabricated speech output. The hands provide an intuitive method for the computer control interface layer. While a user may not have dexterous motor control required to use a touch screen, they may have enough gross motor function to detect desired arm endpoint (hand) direction. In other words, there may be repeatable patterns of motion in the hand, forearm, upper arm, and shoulder that can be used to detect desired hand direction. PediAccess will utilize remaining voluntary control to detect desired hand direction to navigate through a communication matrix. Furthermore, the user will not need to learn an unconventional control method; navigation through a visual communication matrix will be synergistically mapped to their desired endpoint movements by exploiting repeatable upper extremity motion patterns. The proposed PediAccess will provide a compact, wireless, wearable system to improve the speed and accuracy at which children affected by motor and speech impairments can communicate. The device will utilize comfortable, wearable, sensing technology to detect user arm endpoint intention. The system will employ motion sensors including accelerometers and gyroscopes and a Bluetooth radio transceiver and the wireless design will increase safety and allow comfortable wear for long periods of time. Motion will be wirelessly transmitted to a base station tablet computer. Software will collect and process data and provide a visual communication matrix with provided user selectable responses. Quantitative data and coordination patterns processed from the motion sensors will be used as inputs to train and test an algorithm to detect endpoint intention. Algorithms will translate endpoint intention to communication matrix commands. [unreadable] [unreadable]

DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess ParkinTune?, an advanced wireless movement disorder monitor technology to augment stimulation programming (tuning) involved in deep brain stimulation (DBS) procedures for Parkinson's Disease (PD). Major PD symptoms that affect quality of life include tremor, bradykinesia, and rigidity. While the exact mechanism that fuels DBS clinical success stories remains unclear, the procedure has been shown to effectively relieve PD motor symptoms when medication is no longer effective. However, clinicians lack tools that combine physiological, electrical, and behavioral data to optimize electrode placement and stimulator programming. Optimizing electrode placement and stimulator parameters improves the amount of motor symptom reduction patients receive and minimizes complications. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a qualitative ranking system. A battery of exercises, typically a subset of the upper extremity motor section of the UPDRS, is normally completed during DBS electrode placement surgery and subsequent programming sessions to evaluate performance while a clinician qualitatively assesses symptoms. CleveMed has previously developed a compact wireless system to quantify movement disorder symptoms called ParkinSense?. This previously existing technology will serve as the hardware platform for this proposed program. While previous work has shown excellent results to objectively quantify symptoms during a clinical exam, this proposed project will integrate several new features for real-time assistance with DBS surgery electrode placement and stimulation programming. The clinically deployable ParkinTune system resulting from this proposed Fast-Track application will provide a compact wireless system for use in the operating room and outpatient follow up programming sessions that maximizes patient safety and comfort. The objective biokinetic data transmitted during electrode placement and subsequent programming will be input to algorithms that output a continuous scale of objective PD symptom severity in real-time to guide clinician decision making. The improved resolution and repeatable results of the ParkinTune system should reduce time and costs of DBS procedures as well as optimize patient outcomes.