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CleveMed Receives $1.23 Million in NIH Funding to Develop a System to Augment Deep Brain Stimulation Programming in Parkinson's Disease

Wednesday, October 8, 2008 General News
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CLEVELAND, Oct. 7 Cleveland Medical Devices Inc.(CleveMed) announced it has been awarded $1.23 million in NIH SBIR FastTrackfunding from the National Institute on Aging to develop ParkinTune(TM), asystem to augment stimulator programming in deep brain stimulation (DBS)procedures for Parkinson's disease (PD). CleveMed is collaborating withclinicians at the Center for Neurological Restoration of the Cleveland ClinicFoundation, a world renowned, pioneering DBS surgery center.
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"Clinical tools are needed to improve deep brain stimulation proceduresand patient outcomes," said Dr. Jerrold Vitek, Director of the ClevelandClinic Foundation Neuromodulation Research Center and grant collaborator."Assisting neurologists by objectively capturing and tracking motorperformance in response to stimulation settings with a compact wireless deviceshould show efficacy in optimizing patient outcomes in Parkinson's disease."
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DBS is a surgical procedure for treating PD motor symptoms, such astremor, bradykinesia (slowed movements) and rigidity, when medication is nolonger effective. During surgery, an electrode is implanted in a targetedlocation in the brain. Once inserted, the stimulator intensity, frequency andduration are programmed. This programming is also necessary in severaloutpatient sessions over a period of months post surgery. Each time thestimulator settings are changed the patient's motor symptoms are evaluatedusing the Unified Parkinson's Disease Rating Scale (UPDRS) motor exam, asubjective evaluation clinicians use to assess PD motor symptoms. The processis repeated multiple times until optimal stimulator parameters are found whichminimize motor symptoms. Utilizing an automated technology platform toobjectively quantify Parkinson's motor symptoms and suggest optimizedstimulation settings based on those measurements may reduce the time and costof programming sessions as well as improve patient outcomes.

"CleveMed has previously demonstrated efficacy in objectively monitoringmovement disorder motor symptoms," said Dr. Joseph Giuffrida, Director ofCleveMed's Division of Movement Disorders and grant principle investigator."Expanding this technology and knowledge to DBS programming should provideneurologists with an innovative tool for understanding specific neuralmechanisms of DBS on motor control."

The objective is to further commercialize Kinesia(TM), a clinical devicecurrently on the market for monitoring upper extremity PD symptoms, for a newarea of use which will aid clinicians with stimulator programming during DBSsurgery and post surgical tuning sessions to ensure optimal control of motorsymptoms has been achieved. The technology to be developed will furtherstrengthen our product portfolio and leading position in the area ofambulatory monitoring for movement disorders. The system will utilize awireless patient unit worn on the hand that will transmit the kinematic motiondata to a nearby laptop. The laptop will display objective symptom informationand suggested stimulation settings to help the clinician rapidly programstimulation parameters. By providing repeatable and objective biokinetic dataof patient symptoms along with visual examination, ParkinTune may reduce timeand costs associated with DBS surgeries and outpatient programming sessions aswell as increase patient comfort and overall outcomes.

About CleveMed - CleveMed was founded with the goal of developinginnovative telemetry devices for a variety of medical applications. Today,CleveMed is developing and pioneering the use of novel wireless monitoringsystems for high growth neurology and rehabilitation applications, includingbrain monitoring, sleep disorders and movement disorders. Through theseinnovations, CleveMed has developed a growing range of products that addressthe needs of the medical, research and academic communities.

SOURCE CleveMed
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