A Medical Device Daily

Cleveland Medical Devices (CleveMed) said it has been awarded $1.5 million in NIH SBIR Phase II Continuation funding from the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health. The grant will fund further development and clinical validation of Kinesia, a quantitative motor assessment system for evaluating Parkinson's disease symptom severity.

The initiative includes a large multi-center clinical trial with University Hospitals of Cleveland, the University of Cincinnati, and The Clinical Neuroscience Center (Detroit, Michigan) as the participating centers. According to CleveMed, the trial will aid in development of Kinesia for continuous symptom monitoring in patients' homes, as well as further validate the correlation between the device and the Unified Parkinson's Disease Rating Scale (UPDRS).

CleveMed describes Kinesia as a compact lightweight system worn on a patient's wrist and hand, designed to monitor 3-D motion and electrical muscle activity (EMG) to quantify the severity of Parkinson's disease symptoms, such as tremor, bradykinesia (slowed movements) and dyskinesias (wild, involuntary movements). Patients follow on-screen video instruction while data is wirelessly transmitted to a computer.

"Objective quantification of Parkinson's disease symptoms such as tremor, bradykinesia, and dyskinesias is important in light of new pharmaceutical trials and novel therapies such as deep brain stimulation," said Alberto Espay, MD, a neurologist at the University of Cincinnati Movement Disorders Center. "The technology should prove useful for quantifying symptoms in-clinic and tracking symptom fluctuation patterns at patients' homes to more effectively modulate treatments, ultimately improving quality of life for individuals with Parkinson's disease."

A previous clinical study involving 60 Parkinson's patients showed good correlation between Kinesia and the UPDRS, CleveMed noted. The UPDRS, a subjective assessment scale, is the current standard in rating Parkinson's symptom severity.

"Kinesia is being developed as a standardized platform to measure motor symptoms and meets the clinical need for quantifying and tracking symptoms more objectively," said Joseph Giuffrida, PhD, director of CleveMed's division of Movement Disorders. "Using Kinesia with the UPDRS will give clinicians detailed information for basing treatment options, such as medication dosage and timing." This funding will be used to upgrade the system for home use, further validate correlations between Kinesia and the UPDRS and demonstrate efficacy of home monitoring over longer periods of time, such as days, weeks or months, instead of just the snapshot that clinicians see in a typical office exam.

CleveMed develops wireless monitoring systems for high growth neurology and rehabilitation applications, including brain monitoring, sleep disorders and movement disorders.

In contract news, Nightingale Informax (Markham, Ontario) said it has signed a three-year, $3.1 million revenue cycle management contract with Harbor Hospital (Baltimore), a 203-bed hospital with 52 employed physicians and an affiliated network of more than 200 active physicians.

The initial term of the agreement is three years, with an option to renew. Nightingale will receive payment, on a recurring monthly basis, totaling $3.1 million over the initial three-year term of the contract.