A Medical Device Daily

Cleveland Medical Devices (CleveMed; Cleveland) said it has been awarded $1.23 million in SBIR FastTrack funding from the National Institute on Aging of the National Institutes of Health to develop ParkinTune, a system to augment stimulator programming in deep brain stimulation (DBS) procedures for Parkinson's disease. CleveMed said it is working with clinicians at the Center for Neurological Restoration of the Cleveland Clinic Foundation to develop the system.

"Clinical tools are needed to improve deep brain stimulation procedures and patient outcomes," said Jerrold Vitek, MD, PhD, director of the Cleveland Clinic's Neuromodulation Research Center and grant collaborator. "Assisting neurologists by objectively capturing and tracking motor performance in response to stimulation settings with a compact wireless device should show efficacy in optimizing patient outcomes in Parkinson's disease."

DBS is a surgical procedure for treating Parkinson's motor symptoms, such as tremor, bradykinesia (slowed movements) and rigidity, when medication is no longer effective. During surgery, an electrode is implanted in a targeted location in the brain. Once inserted, the stimulator intensity, frequency and duration are programmed. According to CleveMed, this programming is also necessary in several outpatient sessions over a period of months post surgery. Each time the stimulator settings are changed the patient's motor symptoms are evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS) motor exam, a subjective evaluation clinicians use to assess Parkinson's motor symptoms. The process is repeated multiple times until optimal stimulator parameters are found which minimize motor symptoms. Using an automated technology platform to objectively quantify Parkinson's motor symptoms and suggest optimized stimulation settings based on those measurements may reduce the time and cost of programming sessions as well as improve patient outcomes, the company said.

"CleveMed has previously demonstrated efficacy in objectively monitoring movement disorder motor symptoms," said Dr. Joseph Giuffrida, director of CleveMed's Division of Movement Disorders and grant principle investigator. "Expanding this technology and knowledge to DBS programming should provide neurologists with an innovative tool for understanding specific neural mechanisms of DBS on motor control."

CleveMed said the objective is to further commercialize Kinesia, a clinical device on the market for monitoring upper extremity Parkinson's symptoms, for a new area of use which will aid clinicians with stimulator programming during DBS surgery and post surgical tuning sessions to ensure optimal control of motor symptoms has been achieved. The system will use a wireless patient unit worn on the hand that will transmit the kinematic motion data to a nearby laptop, the company said. The laptop will display objective symptom information and suggested stimulation settings to help the clinician rapidly program stimulation parameters. By providing repeatable and objective biokinetic data of patient symptoms along with visual examination, ParkinTune may reduce time and costs associated with DBS surgeries and outpatient programming sessions as well as increase patient comfort and overall outcomes.

In other grant news, Luna Innovations (Roanoke, Virginia) reported an award from the National Cancer Institute of the NIH to improve the detection and diagnosis of brain tumors. Luna will adapt its exclusive contrast agent technology using carbon nanospheres to produce an improved MRI agent. Luna said the next-generation contrast agent will be designed to enhance tumor imaging and advance the diagnosis and treatment of this disease by directing nanomolecules to seek out specific biological targets, such as a glioblastoma tumor, one specific form of brain cancer.

Luna says its imaging technology can be modified to direct it to accumulate at specific targets. Its MRI contrast agent prototype is based on a modification of its Trimetasphere carbon nanomaterial known as the Hydrochalarone, which the company says has shown promise to significantly enhance relaxivity, a property that provides for better imaging; is extremely stable; is water soluble; and has the potential to be modified to clear from the bloodstream quickly or slowly, depending on the specific application.

"Luna's Hydrochalarone technology platform can be modified to produce targeted contrast agents, which selectively highlight the tumor cells. Our hope is that our novel approach will provide better resolution to radiologists, who in turn, will improve patient outcomes," said Kent Murphy, Luna CEO/chairman.

Last November, Luna reported its first grant with the NIH using this carbon nanotechnology platform to improve the identification of coronary artery disease. Under this program, Luna proposed to develop a diagnostic agent that would allow the use of MRI, potentially providing a noninvasive measure to evaluate plaque in the arteries without the use of ionizing radiation and catheters.

The company's contrast agent prototype is in preclinical studies at the NCI's Nanotechnology Characterization Laboratory. The outcome of this characterization study is the report necessary for an Investigational New Drug application, Luna noted.