Medtronic's Activa DBS Therapy Improves Quality Of Life And Motor Function Significantly

Main Category: Parkinson's Disease
Also Included In: Clinical Trials / Drug Trials;  Neurology / Neuroscience
Article Date: 09 Sep 2006 - 23:00 PDT

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Medtronic's Activa® DBS therapy improved quality of life and motor function significantly more than medication alone in first head-to-head trial.

According to the results of a major European study published in the August issue of The New England Journal of Medicine (NEJM), Activa Deep Brain Stimulation (DBS) Therapy has been shown to be significantly more effective for the treatment of Parkinson's disease than traditional medication alone.

The study sought to evaluate improvements in motor function and quality of life after six months of treatment. Patients were randomly assigned to one of two treatment groups: half received DBS plus medication; the other half received medication alone.

The study reports that patients in the DBS group experienced a 25 percent average improvement in quality of life scores, and a 41 percent average improvement in motor function. These improvements were significant and substantial. This compared with no change on either measure among those patients in the non-DBS group.

Gunther Deuschl, professor and chairman of neurology at the University of Kiel in Germany, and the lead author of the article, explained the significance of the study's results, "DBS clearly provides important benefits to Parkinson's patients who suffer troubling motor symptoms despite optimal treatment with medication. It should therefore be routinely offered to Parkinson's patients as soon as medication begins to lose its effectiveness or cause side effects that interfere with quality of life."

Conducted at ten academic medical centres in Europe, the study involved 156 patients with severe motor complications of Parkinson's disease. All patients were under 75 years old and had been diagnosed with Parkinson's disease at least five years previously. They were also suffering severe mobility and movement problems, despite optimal treatment with medication.

Affecting an estimated 800,000 people in Europe, Parkinson's disease is a complex, progressive and degenerative neurological disorder that causes loss of control over body movements. Motor symptoms include rigidity; bradykinesia/akinesia (slowness/absence of movement); and tremor (involuntary, rhythmic shaking of a limb; the head, mouth, or tongue; or the entire body). Parkinson's disease has no known cause or cure. Symptoms arise when a small region of the brain called the substantia nigra, or "black substance," degenerates. As cells in this region die, the brain becomes deprived of the chemical dopamine. Reduced dopamine leads to the symptoms of Parkinson's disease. As it progresses, Parkinson's disease becomes increasingly disabling, making routine daily activities like bathing, dressing, and eating difficult or impossible without assistance.

Besides DBS, treatment options for Parkinson's disease include drugs and surgery. Introduced more than 30 years ago, the drug levodopa remains the gold standard for initial treatment of Parkinson's disease. After about five years, however, treatment with levodopa and similar drugs often creates intolerable side effects that can be worse than the disease itself; side effects include dyskinesia and fluctuations in motor control featuring periods of complete immobility. A surgical procedure called pallidotomy involves the destruction of specific cells in the brain's pallidum. Pallidotomy, however, is irreversible and cannot be performed bilaterally - that is, on both sides of the brain - without the risk of serious consequences or permanent side-effects such as loss of speech.

Activa DBS Therapy reduces the motor symptoms of Parkinson's disease by modifying abnormal neuronal activity in the brain's movement centre. It involves the implantation of a medical device similar to a cardiac pacemaker that delivers electrical pulses to precisely targeted areas of the brain involved in motor control. The stimulation can be adjusted non-invasively as the disease progresses to meet changing patient needs.

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More than 30,000 people worldwide have received Activa DBS Therapy, which is approved for the treatment of three movement disorders - Parkinson's disease, essential tremor and dystonia. According to a survey conducted by Medtronic in January 2006, two out of three patients said they wished that they had opted for DBS sooner. Information for patients about Activa DBS Therapy can be obtained online at http://www.newhopeforparkinsons.com.

Medtronic, Inc. (http://www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

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Medtronic, Inc.

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