If you attend a Parkinson’s disease event, you will may meet people who swear by deep-brain stimulation surgery (DBS). It has helped approximately 30,000 people regain motion, and decrease tremors. However, testimonials alone are dangerous. What happens when we compare a group of people who had DBS, with a group of people who use medication only? Who fares better?
DBS really came on the scene in 1997, when researchers attempted to show that it was safe and effective. The work of a French team lead by Alim-Louis Benabid, M.D., Ph.D. indeed proved it was effective, and that it was generally safe. More recently a large group of more than 30 German and Austrian doctors and researchers decided to put DBS to a more stringent test. They combined information from many of their patients to measure the effect of DBS. Could it beat medications, and relieve more Parkinson’s symptoms?
Today the New England Journal of Medicine released the results of the German team’s work. The found that Medtronic’s DBS therapy, combined with medication, is significantly more effective than medication alone in treating motor symptoms of advanced Parkinson's disease.
The study included 156 patients with severe motor symptoms of Parkinson's disease and rated improvements after six months of treatment. Patients were randomly assigned to one of two treatment groups: half were selected to receive medication plus bilateral DBS of the subthalamic nucleus (STN), a brain structure involved in regulating movement, using Medtronic's Kinetra(R) neurostimulation system. The other half were selected to receive medication alone. At the time of enrollment in the trial, all patients were under 75 years old, had been diagnosed with Parkinson's disease at least five years previously, and suffered from impaired mobility despite treatment with medication.
Compared to medication alone, DBS of the STN caused significantly greater improvements in motor function after six months. On average, patients who received DBS plus medication showed a 41 percent improvement in motor function (as measured by the motor examination component of the Unified Parkinson's Disease Rating Scale (UPDRS-III)). Medication-only patients showed no change on the same measure.
Lead author Dr. Gunther Deuschl, professor of neurology and chairman of the Department of Neurology at the University of Kiel in Germany, 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 offered to this group of patients as soon as mobility problems can no longer be managed sufficiently with medication."
While serious adverse events were more common with neurostimulation than with medication alone and included a fatal intracerebral hematoma, the total number of adverse events was higher among medication-only patients. The authors stated that all of the non-fatal adverse events "resolved without permanent complications" and that "most adverse events were well-known medical problems associated with advanced Parkinson's disease."
According to Dr. C. Warren Olanow, professor of neuroscience and chairman of the Department of Neurology at the Mount Sinai School of Medicine in New York, and former president of the Movement Disorder Society: "This study provides further evidence supporting the use of DBS as a therapy for advanced Parkinson's disease patients whose motor symptoms cannot be satisfactorily controlled with medication."
Dr. Olanow served as a lead investigator in the global clinical trial of DBS for Parkinson's disease that led to the therapy's approval by the U.S. Food and Drug Administration in January 2002.
Introduced more than 30 years ago, the drug levodopa remains the gold standard for the initial treatment of Parkinson's disease. After about five to seven years, however, treatment with levodopa typically causes motor complications such as dyskinesia and fluctuations in motor control that can lead to intolerable disability in many patients. Activa® DBS Therapy reduces some of the motor symptoms of advanced Parkinson's disease. It involves the implantation of a medical device that delivers electrical pulses to precisely targeted areas of the brain involved in motor control. The stimulation can be adjusted without surgery, as the disease progresses to meet changing patient needs.
If you would like to explore Activa ® DBS therapy, and explore its potential to help you or someone you care about, please click here to request more information.
Source: New England Journal of Medicine, August 31, 2006: Volume 355:896-908, Number 9
