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Old 04-10-2014, 05:23 PM
Tupelo3 Tupelo3 is offline
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Join Date: Mar 2013
Location: New Jersey
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10 yr Member
Tupelo3 Tupelo3 is offline
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Join Date: Mar 2013
Location: New Jersey
Posts: 832
10 yr Member
Default Early Stage Parkinson’s Disease DBS trial receives FDA approval

DBS as an early stage, first line treatment. It will be very interesting to follow the results of this study.


A long-term Vanderbilt University Medical Center study of deep brain stimulation (DBS) in early stage Parkinson’s disease has received approval from the Food and Drug Administration (FDA) to continue in a pivotal, phase III, large-scale safety and efficacy trial. Approximately 350 patients will be recruited at 15 academic medical centers in the U.S. and Europe for this Vanderbilt-led study.

“Our hypothesis is that patients who have DBS applied in the very early stage of Parkinson’s disease will do much better in quality of life and motor function and have delayed onset of disability and medication-associated complications. Expanding the trial will help test that hypothesis.”

“We believe strongly and have always been working from the controversial point of view that DBS and medication is better than medication alone,” Charles said.

With an estimated 50 percent of dopamine-producing cells already degenerated when a patient first shows symptoms, time is of the essence in applying any therapy that may slow the progression of Parkinson’s. "Half the cells you are trying to save are already gone the day you make the diagnosis. We stand behind early DBS because we believe the treatment could stave off the loss of more of those cells,” Charles said.

http://www.elkvalleytimes.com/?p=27809
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