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St. Jude Medical Completes Study of DBS for Parkinson's Disease By: Madeline Ellis Published: Thursday, 11 June 2009 Related articles a.. L-type Calcium Channel Blockers May Reduce Risk of Parkinson's Disease St. Jude Medical, Inc. says they have completed patient implants in its U.S. clinical study of deep brain stimulation for the symptomatic treatment of Parkinson's disease, a degenerative neurological disorder that often impairs motor skills, speech and other functions, progressively diminishing the person's control over his or her movements. This accomplishment, announced at the Movement Disorder Society's 13th International Congress of Parkinson's Disease and Movement Disorders in Paris, comes just months after St. Jude gained European CE Mark approval of its Libra and Libra XP DBS systems. "We are excited by the progress we've made in bringing the Libra deep brain stimulation systems to the market," said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. "The completion of patient implants in this study and our recent European CE Mark approval represent significant steps towards our goal of providing physicians with an innovative deep brain stimulation system for treating Parkinson's disease." Ongoing at fifteen medical centers in the U.S., the randomized, controlled study is evaluating the safety and effectiveness of the St. Jude Medical's DBS systems in 136 participants who have lived with the disease for more than five years and whose symptoms were insufficiently controlled with medication alone. "The progressive nature of Parkinson's disease often leads patients to a point where medication management alone can no longer adequately control the symptoms of the disease," said Dr. Bruno Gallo, assistant professor of neurology at the University of Miami in Florida and an investigator in the study. "Because these patients often become unable to care for themselves, we need to look for additional methods of treating this debilitating condition in order to help improve a patient's quality of life." Deep brain stimulation (DBS) uses surgically implanted medical devices called neurostimulators, similar to cardiac pacemakers, to deliver electrical stimulation to precisely targeted areas on each side of the brain, either the subthalamic nucleus (STN) or the globus pallidus interna (GPi), to influence nerve cell activity in these regions. As a result, many patients achieve greater control over their body movements. A recent study published in the Journal of the American Medical Association concluded that DBS was a more effective treatment than best medical therapy for the management of moderate to severe Parkinson's disease. A DBS system includes three components: a neurostimulator, which is the power source for the system. It contains a small battery and computer chip programmed to send electrical pulses; the lead, which is an insulated wire with four electrodes that is implanted in the brain, with its tip positioned within the targeted brain area; and an extension, an insulated wire placed under the scalp that connects to the lead and runs behind the ear, down the neck, and into the chest below the collar-bone where it connects to the neurostimulator. Once in place, electrical impulses are sent from the neurostimulator up along the extension wire and the lead and into the targeted brain area. The Libra and LibraXP neurostimulators feature the largest battery capacity of any DBS device in their class, which may maximize the time between device replacement procedures, and can be non-invasively adjusted by a clinician to meet individual patient needs. "Ultimately patients benefit from the development of new technologies," said Dr. Michele Tagliati, associate professor of neurology and division chief of movement disorders at Mount Sinai Medical Center in New York who enrolled the first patient in the study. "We are hopeful the Libra deep brain stimulation systems will prove effective at reducing the symptoms of Parkinson's disease and provide additional tools to better control this debilitating condition." The National Parkinson's Foundation estimates that 1 in every 100 people in the U.S. over the age of 65 has the disease. Research suggests that men are two to three times more likely to be diagnosed with the disease than women. Parkinson's disease affects an estimated 6.3 million people worldwide, according to the European Parkinson's Disease Association. Rayilyn Brown Director AZNPF Arizona Chapter National Parkinson Foundation [log in to unmask] ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn