The conclusions from a major study on deep-brain stimulation (DBS) published in the New England Journal of Medicine today seemed rather anti-climatic, at least on the surface.
There was no real difference between implanting a DBS device in the globus pallidus interna (GPI) and subthalamic nucleus (SN) regions of the brains in patients suffering from Parkinson’s disease. Each worked equally as well.
But for Medtronic Inc. (NYSE: MDT), which funded the study, the results are significant because it gives doctors more flexibility (and clinical comfort) in using its Activa PC and RC devices, the first and only DBS devices approved by the Food and Drug Administration to treat movement disorders in the United States.
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And greater flexibility means a greater pool of potential patients.
Medtronic’s neurostimulation sales in fiscal 2010 rose 9 percent to $1.6 billion, driven largely by sales of Activa.
Doctors tend to target the SN region for DBS therapy even though there’s no evidence that location produces better results than GPI. So researchers randomly implanted Medtronic devices in either region in 300 patients across the country and compared the results.
(The federal Department of Veteran Affairs, the National Institute of Neurological Disorders and Stroke and Medtronic paid for the study. The study insisted Medtronic had no role in designing the study or interpreting the results though several of the authors have received grants, lecturing and consulting fees from the company.)
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After 26 months, patients in both group reported significant improvement in motor control, the primary objective of the study, as measured by the Unified Parkinson’s Disease Rating Scale (UPDRS). The scale measures motor control in areas like speech, facial expression and hand tremors on a zero to four-point system: zero means no symptoms or normal function while four indicates severe symptoms or interference in function.
Overall, the GPI group reported an 11.8-point reduction while SN patients boasted a 10.7-point decline.
“Improvement in motor function as measured by UPDRS-III motor scores did not differ significantly according to the target of deep-brain stimulation, and we cannot conclude that one target is superior to the other on the basis of this measure,” the authors wrote. “Both sites are feasible targets.”
“The absence of a difference in motor outcomes in the two study groups should serve to reassure clinicians that the choice of target need not focus solely on improvement in motor function,” they continued. “The selection of the target can reasonably take into consideration the constellation of motor and non-motor symptoms that define quality of life for patients with Parkinson’s disease.”
Medtronic officials quickly praised the study.
“Data collected from this study demonstrate not only the long-term efficacy of Medtronic DBS Therapy for Parkinson’s disease, but also the positive impact the therapy has on patients,” Tom Tefft, president of the Neuromodulation business and Medtronic senior vice president, said in a statement.
