Archive for April, 2009

CleveMed working with the Cleveland Clinic to assist with Deep Brain Stimulation Tuning

Thursday, April 30th, 2009

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.

Deep Brain Stimulation Surgery as a Treatment for Parkinson’s Disease

Wednesday, April 22nd, 2009

Parkinson’s disease (PD) is a neurodegenerative disorder that is caused by the death of dopamine producing neurons in the brain. Primary motor symptoms of PD include tremor, rigidity, bradykinesia (slowed movements or hesitations) and gait and balance issues. Since there is currently no cure for PD, the symptoms are treated typically with pharmaceutical interventions.

One of the more common medications prescribed for PD is L-Dopa, which is used to increase levels of dopamine in the brain. While effective, a common issue with the use of L-Dopa is that there is a fine line between the correct amount of medication and too much. Too much medication results in dyskinesias, or wild, uncontrollable movements. Also, the effectiveness of L-Dopa decreases over time.

When L-Dopa is no longer effective as a treatment for PD symptoms, patients can consider a surgical procedure called deep brain stimulation, or DBS. When patients opt to have DBS surgery, tiny electrodes are implanted in the brain through a hole in the skull which emit pulses of stimulation that aide in symptom alleviation. The location of the electrode can vary depending on the patient but the two most common are subthalamic nucleus (STN) and the globus pallidus interna (GPi). A patient can also have electrodes implanted on one side of the brain or both, depending on whether their symptoms are unilateral or bilateral. The electrode or electrodes connect to a pulse generator which is typically implanted below the skin near the collarbone. The implanted pulse generator, or IPG, controls the electrode stimulation output. Parameters such as amplitude (the power of the stimulation), frequency (how often the stimulations pulses occur) and duration (how long each pulse lasts) must be set.

During DBS surgery the patient is awake and fully aware. This is because a nurse must perform motor assessments with the patient to determine if the electrode has been placed in an optimum location and depth. This assessment includes motor tasks that the patient is asked to complete to determine the severity levels of their symptoms. This can sometimes be time consuming as the patient must complete the assessment each time the electrode is moved.

Once surgery is completed, patients will return to the clinic to have the IPG settings adjusted. Again, a nurse will administer a motor assessment and alter the amplitude, frequency and duration of the pulses until an optimum combination is found with best alleviates the patient’s symptoms. This adjustment is repeated a number of times as symptoms worsen due to the progression of the disease.

While the exact reason DBS works is still not known, the number of PD patient lives the surgery has improved is dramatic. Patients with debilitating motor symptoms that leave them nearly incapable of performing activities of daily living can have the ability to move and function as they did before their diagnosis of PD. This is not to say that DBS does not have risks. It is a major surgical operation and results are not the same for each patient. The first step to determining whether or not DBS would be appropriate for any PD patient would be to discuss their options with a certified movement disorder clinician or neurologist.

PSG Anywhere™:
Expanding the reach of your Sleep Services

Wednesday, April 15th, 2009

As the market changes it is rapidly becoming important to offer flexible solutions for collecting sleep studies at varied locations. With the entrance of Wireless Polysomnography, sleep study setups outside of the lab become more feasible. A comprehensive sleep diagnostic service can now come to the patient instead of the patient having to come to the lab for a PSG. Wireless PSG also brings several benefits to the traditional in-lab setting. Here’s a quick introduction to the traditional and new & upcoming, non-traditional settings for a polysomnography.

Traditional Setting:

In-lab sleep facilities offer onsite sleep techs, medical equipment, and a full bedroom set. This is an expensive set-up, but wireless PSG completely eliminates the cost of running cables throughout the facility with its ability to transmit data through multiple walls. Also, there are typically fewer components with wireless devices and lower risk of individual component failure. Sleep labs will also benefit from expanding their sleep services to include non-traditional off-site testing. Sleep labs volume will not diminish but their patient mix will differ. Typically overcrowded labs will only have deal with those who strictly require in-lab testing, and they can service a larger total volume of patients (since they do not all need to be onsite). Each patient population can then receive a faster diagnosis and therefore faster treatment initiation, cutting out the need for long waits or investing in additional beds for the lab.

Non Traditional Settings:

Home Sleep Test: While some extreme conditions strictly require in-lab sleep testing, many patient populations are well suited for home sleep diagnostic testing, like those tested for occupational reasons, or the home-bound suffering from chronic pain. Home Sleep Testing (HST) allows patients the comfort of home and a familiar environment. It is also increases affordability by cutting out the facility costs of the sleep lab, and the costs involved in moving a patient to the sleep lab which can be expensive in some cases.

Hospital Inpatient PSG: Hospital networks, wireless or intranets are used to transfer sleep studies from the bedside to the sleep lab. Technicians can monitor and respond to problems, yet the patient is still under the immediate supervision of skilled nurses. Since Sleep Disorders Breathing is a complicating factor in many surgeries, the ability to conveniently conduct a sleep study in those settings may avoid complications intraoperatively and postoperatively (particularly for bariatric and cardiac surgery patients)

Hotels: Sometimes sleep labs use hotel rooms to conduct sleep studies because of reduced costs. Some patients are better able to relax in this more familiar setting, and benefit from a reduced first-night-effect.

CleveMed offers the technologies that can expand the reach of sleep services with its wireless systems that are suitable for both HST, follow-up and in-lab sleep studies. This post draws on the experience of several experts at CleveMed and the following web page: www.clevemed.com/PSGAnywhere

Why Wireless?

Wednesday, April 8th, 2009

CleveMed is a medical device company that specializes in developing and manufacturing miniaturized wireless monitoring devices for the clinical, research and educational fields. Every device that is developed, whether it’s for sleep disorder monitoring, movement disorder monitoring, physiological research or biomedical engineering education, is wireless and handheld or patient worn. So, why the emphasis on wireless technology?

Wireless devices are emerging as a stronghold in the medical device and research fields because of the many advantages the technology offers. Wireless equipment gives the patient or subject being monitored the ability to move freely and naturally. Using a wireless device while monitoring a patient for a sleep disorder provides the ability to get up during the study and move around without the need to be disconnected. Wireless physiological monitoring equipment increases the environments in which a subject can be monitored, such as running on a treadmill or riding a bike.

In addition to increased applications, wireless equipment increases patient and subject safety. The need to be connected to a computer or large cart mounted system is eliminated when using a wireless device. Large obtrusive wires are not necessary and not a concern to the user, letting them move naturally without the worry of pulling on wires that are connected to computers or large cart mounted systems. Wireless also means that the user does not need to be connected to any power outlets, as all CleveMed devices are powered by batteries.

Many organizations are taking advantage of the increased flexibility and reduced costs that wireless devices offer. Using wireless systems can help turn any room into a sleep lab, motion analysis center or physiological monitoring research room because there is no need for complicated wiring or extensive setup.