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.

The American Medical Association CPT (Current Procedural Terminology) Editorial Panel has approved the release of CPT^® code 0199T: Physiologic recording of tremor using accelerometer(s) and gyroscope(s), (including frequency and amplitude) including interpretation and report. Implementation date is July 1, 2009.

CleveMed has worked diligently with key personnel as well as members of the American Medical Association on the implementation of the 0199T Category III code to cover Kinesia^TM, a wireless patient worn device for objectively monitoring the severity of movement disorder motor symptoms.

Currently, Kinesia is the only device on the market that uses accelerometers AND gyroscopes, as defined in the description of the code, for the physiologic recording of tremor.

Kinesia is a compact device worn on the hand and wrist of the patient while they complete a video-guided upper extremity motor symptom evaluation. Symptom severity information is wirelessly telemetered to a nearby computer, increasing patient mobility and simplifying setup, where it is displayed and stored. Tasks for evaluating tremor, including rest, postural and kinetic, are automatically scored on a 0 to 4 scale. Severity scores can be viewed in customizable patient reports.

If you have questions regarding Category III codes, reimbursement or other information, please contact a CleveMed representative at 1-877-253-8363 or visit our website at www.CleveMed.com.

CleveMed is currently working with the Center for Neurological Restoration at the Cleveland Clinic to monitor motor symptoms during and after Deep Brain Stimulation surgery. To learn more about DBS, click here. Currently, motor symptoms are evaluated during multiple times during DBS surgery to determine if the optimal electrode placement has been determined. Kinesia is being used to evaluate if better methods are available for measuring these symptoms to decrease the duration of the surgery, which can last for hours while the patient is fully conscious, and increase patient comfort. One potential application is to have the patient wear the device while their motor symptoms are being evaluated. The output of Kinesia could then be used as an objective measure from which to base the movement of the electrode.

In addition to the evaluations performed during the surgery, patients need to return to the clinic post surgery to optimize the stimulator settings once the surgical location is completely healed. Here, a nurse or clinician will evaluate the motor symptoms and adjust parameters of the stimulator such as frequency, amplitude and pulse width. As the settings are adjusted, the patient completes an upper extremity evaluation and this is sometimes completed multiple times, which can result in fatigue and therefore, not the most appropriate settings. Here, Kinesia can be worn by the patient while they complete these exams and the output of the device can be correlated to the most optimal stimulator settings. This can decrease the length of time of the visit, as well as increase patient comfort. If the device is able to suggest actual setting parameters, stimulator tuning can be completed in a typical clinician’s office instead of having the patient go to specialty movement disorder centers.