Wireless Movement Disorder Monitor
Small Business Information
CLEVELAND MEDICAL DEVICES, INC.
4415 EUCLID AVE, CLEVELAND, OH, 44103
AbstractDESCRIPTION (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 quant ifying 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 journal s. 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) amplifie rs, 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 tre mor, 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. Add itionally, 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 mark et. 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 pati ent 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 de veloped 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.
* information listed above is at the time of submission.