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From: VA Media Relations <[log in to unmask]>
To:  [log in to unmask]
Date: Tue, 13 Jan 2009 13:46:30  -0500
Subject: Release - VA-NIH Study Offers Hope for Parkinson's  Patients


VA-NIH Study Offers Hope for Parkinson's  Patients

Study Says Deep-Brain Stimulation Has Benefits

WASHINGTON (January 13, 2009) -- Electrical stimulation of the  brain -- a 
treatment in which a pacemaker-like device sends pulses to electrodes  implanted 
in the brain -- is riskier than drug therapy but may hold significant  
benefits for those with Parkinson's disease who no longer respond well to  
medication alone.
That is the conclusion of researchers  from the Department of Veterans 
Affairs (VA) and National Institutes of Health  (NIH) who conducted a six-year study 
comparing deep-brain stimulation (DBS) to  medication, along with speech, 
physical or occupational therapy, given as  needed.  The results of the trial, 
the largest of its kind to date, appear  in the January 7 Journal of the 
American Medical Association (JAMA).
"Deep-brain stimulation offers hope for a large number of patients  with 
advanced Parkinson's disease who suffer from complications of long-standing  
medication therapy," said Secretary of Veterans Affairs Dr. James B. Peake.  "This 
finding could mean improved quality of life for some of our  patients."
The study included 255 Parkinson's patients  at seven VA medical centers and 
six university hospitals.  The VA sites  were Portland, Ore., Seattle, San 
Francisco, Los Angeles, Houston, Richmond,  Va., and Philadelphia, all members of 
VA's network of Parkinson's Disease  Research, Education and Clinical Centers.
The JAMA  article also noted VA's nationwide system of hospitals and 
specialized centers  of excellence make the Department uniquely capable of conducting 
such large,  multi-site trials of new therapies and medical devices.  VA's 
patient  population is especially suited for trials of treatments for chronic 
disease in  the elderly.
Patients who took part in the study were on  medication but are no longer 
seeing improvements in symptoms such as tremors or  stiffness. Many were also 
developing side effects from the drugs, such as  involuntary face, arm or leg 
movements. 
Researchers  followed the patients for six months, finding:
*  Patients who received DBS gained an average of 4.6 hours per day of good 
motor  control and few or no involuntary movements, compared with no gain for 
those on  medical therapy alone; 
      * 71 percent of DBS patients showed  significant gains in motor 
function, compared with only 32 percent of drug  therapy patients; and 
* Serious adverse  side effects were nearly four times more common in the DBS 
group, but almost all  of these effects in both groups were resolved during 
the six-month study.   The most common side effects from DBS were infections, 
falls, depression, gait  and balance problems, and pain.
Lead authors and  study co-chairs were Frances Weaver, PhD, a researcher with 
the Center for  Management of Complex Chronic Care at the Hines VA Hospital 
near Chicago, and  Dr. Kenneth Follett, a neurosurgeon at the Omaha VA Medical 
Center and  University of Nebraska.  They emphasize that besides the higher 
likelihood  of serious side effects with DBS compared with drug therapy, another 
drawback of  the procedure is that, although it generally improves movement, 
it does little  to help other Parkinson's symptoms such as depression, decline 
in mental  ability, gait and balance problems, and trouble with 
gastrointestinal, urinary  or sexual function.
"The results of the study should not  be over- or under-stated," said Dr. 
Michael Kussman, VA's Under Secretary for  Health.  "Still, there are many good 
candidates for DBS among patients with  Parkinson's disease whom we treat in 
VA."
The trial was  sponsored by VA's Cooperative Studies Program and the National 
Institute of  Neurological Disorders and Stroke, part of the National 
Institutes of Health.  Additional support came from Medtronic, which makes the DBS 
system used in the  study. 
Parkinson's disease, a progressive neurological  disorder, affects some 1.5 
million Americans, with 50,000 new cases diagnosed  annually. VA treats at 
least 40,000 veterans with the disorder each year.   Most patients are over age 
50, but some forms of the disease can strike younger  adults.




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