CleveMed Blogs

One of the most difficult aspects of monitoring Parkinson’s disease (PD) motor symptoms, is that the severity of tremor and bradykinesia (slowed movements) greatly fluctuates throughout the day.

When medication is at its peak effectiveness, the patient is said to be “On.” Similarly, when medication has completely worn off, the subject is said to be “Off.” Symptoms are often worst first thing in morning, but improve after the first dose of medication. However, as the medication wears off, symptoms return mid-day. These cycles of waxing and waning motor symptoms continue throughout the day. Controlling these “On” and “Off” cycles can be difficult, as patients with PD are typically evaluated in the neurologists’ office, which only allows the physician to capture a snapshot of motor symptoms. Furthermore, patients typically are instructed to refrain from taking medication the night prior to the office visit. A state of anxiety in this condition may amplify PD symptoms during motor evaluation. Monitoring motor symptoms at home would provide clinicians with improved tracking of these complex motor fluctuations and in-turn optimize medication dose to improve patient quality of life.

Kinesia is a compact wireless system developed by CleveMed to quantify movement disorder symptoms. In clinical trials, Kinesia objectively quantified tremor and bradykinesia in PD patients in the clinic. Objective symptom ratings output by the Kinesia system were highly correlated to clinician ratings. CleveMed has recently begun a clinical study in which the Kinesia system is being used throughout the day, at home, by patients with PD. Preliminary results demonstrate that Kinesia can capture the “On” and “Off” motor symptom fluctuations in a subject’s home. Monitoring PD symptoms on a more continuous basis at a patient’s home should improve clinical outcomes and decrease costs especially for disparate patient populations in areas not in close proximity to movement disorder specialists.

While most people know what tremor is when they see it, they may not realize that many different types of tremor exist and why it is important to recognize them. The current gold standard of visual assessment may be blind to subtle characteristics unique to different tremor types. Tremor is a common motor symptom associated with a number of neurological disorders. Defined as rhythmic, involuntary, to-and-fro movements of a body part, tremor is most common in the hands, but can occur in the arms, legs and head. Tremor can be an especially debilitating movement disorder symptom and make activities of daily living, such as dressing, eating and writing, difficult or sometimes impossible without the help of a family member of caretaker.

Several movement disorders produce tremor as a motor symptom. The two most common are essential tremor (ET) and Parkinson’s disease (PD). ET is a common disorder characterized by uncontrolled trembling of the hands and often involuntary nodding of the head. It is the most prevalent movement disorder, affecting nearly 10 million people in the United States alone. PD is a progressive disease associated with the destruction of brain cells that produce dopamine and characterized by muscular tremor, slowing of movement, partial facial paralysis and peculiarity of gait and posture. There are currently about 1 million people in the United States living with PD.

In addition to different disorders producing tremor, different tremor types may exist within a particular disorder, each with unique physical characteristics. Two of these important characteristics are amplitude and frequency. Amplitude refers to how big the movement is while frequency refers to the speed or rate at which the oscillation is happening. Rest tremor is one type that occurs when the affected limb is completely at rest. Resting tremors occur at a specific frequency, usually 4 – 7 Hz, and are most commonly associated with PD, but in some cases found in other movement disorders. Postural tremor occurs when a specific body part is held motionless against gravity, such as extending the arms out, pointing with the hands or sitting upright without back support. Postural tremor typically occurs at a frequency of 9 – 11 Hz and can be associated with PD or ET. Other types of tremor include kinetic tremor, which occurs during a voluntary movement such as writing, drinking or eating and intention tremor, which is unique in that is occurs during a visually guided movement toward a target destination.

Distinguishing tremor types and quantitative features is very important for research, clinical judgments and intervention efficacy. CleveMed has developed a device called Kinesia™ that can be used to detect and monitor subtle differences in tremor characteristics. Kinesia is a small wireless device worn on the patient’s finger and wrist to monitor three dimensional motion. Currently being evaluated in several clinical studies around the United States, this device is intended to help standardize tremor evaluations and provide clinicians with a tool to better quantify tremor features when the signs are too subtle for clinical differentiation alone. Improving and standardizing the clinical evaluation of tremor may ultimately improve the understanding of tremor subtypes, increase efficacy of interventions and maximize patient quality of life.

CleveMed has announced the promotion of Joseph P. Giuffrida, PhD to Vice President, General Manager of the Division of Movement Disorders. CleveMed is continually expanding as a medical device company and Dr. Giuffrida will continue to fill a crucial role to assist with the company’s success.

Dr. Giuffrida, 33, completed his BS, MS and PhD in Biomedical Engineering at Case Western Reserve University with a concentration in rehabilitation engineering. He began his career at CleveMed in 2000 as an Applications Engineer and upon receipt of his PhD in 2004, became a Principal Investigator and eventually Director of the Division of Movement Disorders. Within these roles, Dr. Giuffrida has secured over $10 million in funding from both the National Institutes of Health and the State of Ohio to fuel the research, development, and commercialization of innovative medical devices focused on aiding in the diagnosis and therapy of movement disorders. He has secured FDA clearance to market for a number of CleveMed systems, managed reimbursement strategies for new and emerging technology, established multiple world renowned key opinion leaders and clinical consultants, and lead the marketing and sales teams for CleveMed’s clinical movement disorder products as well as the research and education product lines.

Most notably, CleveMed’s Division of Movement Disorders commercialized and launched Kinesia under Dr. Giuffrida’s direction. This technology is intended to provide a standardized platform for objectively quantifying motor symptoms associated with Parkinson’s disease. Additional research and development in this Division is focused on extending the market applications for Kinesia from clinical office visits to home monitoring and deep brain stimulation programming, assistive technologies to aid in communication for persons with limited mobility and speech impairment and the development of rehabilitation systems to aid in motor recovery after brain injuries such as stroke or cerebral palsy.

In addition to the Division of Movement Disorders, Dr. Giuffrida also manages CleveMed’s line of products focused on the research and education market. Dr. Giuffrida was able to commercialize CleveMed’s wireless physiological monitoring technology into specific academic and university based target applications to increase CleveMed’s sales both domestically and internationally.

CleveMed has collaborated with Dr. Joe Jankovic at the Baylor University Parkinson’s Disease Center and Movement Disorders Clinic using CleveMed’s Kinesia device for essential tremor symptom evaluations. Kinesia is currently used for Parkinson’s disease symptom evaluations but this study may help broaden the potential applications the device can be used for.

The current methods of evaluating essential tremor symptom severity are the Essential Tremor (ET) clinical rating scales. These are similar to the Unified Parkinson’s Disease Rating Scale in which a visual assessment by a clinician produces a numeric score that correlates to symptom severity. Recently, the Tremor Research Group developed The Essential Tremor Rating Assessment Scale, or TETRAS, for the assessment of action tremor in ET. The TETRAS scale utilizes a half point interval, 0 to 4 scale to rate symptom severity.

In this study, our collaborators at Baylor University compared the output of Kinesia to the scores assigned to patients using the TETRAS for upper extremity postural and kinetic tremor. More information on the methods used are available on this poster, which was presented at the Movement Disorder Society Annual Meeting in June 2009, Paris France: Read here. The study concluded that there was a significant correlation between the TETRAS score and the output of the Kinesia system and that the system may provide a useful adjunct to the current subjective rating scales.