CONTACT: JENNIFER BROWN
Iowa City IA 52242
(319) 335-9917; fax(319) 384-4638
Release: Oct. 22, 2002
UI neurosurgeon to lead multi-center clinical trial of surgery for Parkinson's
University of Iowa professor of neurosurgery will lead a national multi-center
clinical study to compare deep brain stimulation with medication therapy for
treating Parkinson's disease. The $14 million, six-year study is jointly funded
by the United States Department of Veterans Affairs and the National Institutes
of Health and will be conducted at 12 medical centers (six Veterans Affairs
medical centers and their affiliated academic medical centers) nationwide.
"We believe that this is the largest trial of surgery for Parkinson's
disease that has ever been put together," said Kenneth Follett, M.D.,
Ph.D. (left), UI professor of neurosurgery, a staff physician at the
Veterans Affairs Medical Center (VAMC) in Iowa City and the study's national
principal investigator. "The expertise within the VA's Cooperative Studies
Program has been invaluable in allowing us to do this study," he added.
Frances Weaver, Ph.D., deputy director of Midwest Center for Health Services
and Policy Research at Hines VA Hospital and research associate professor
at Northwestern University; and Matthew Stern, M.D., director of the Parkinson's
Disease and Movement Disorders Center at the University of Pennsylvania Health
System located at Pennsylvania Hospital, and professor of neurology at University
of Pennsylvania; are national co-principal investigators on the study.
Gatana Stoner, a UI research nurse in neurosurgery, is the national nurse
coordinator for the study, and Matthew White, M.D., UI assistant professor
of radiology, is a co-investigator for UI portion of the study. White will
evaluate MRI brain scans of study patients.
Deep brain stimulation is a surgical therapy for Parkinson's disease. It
involves implanting a thin stimulation wire into brain regions that seem to
be responsible for causing Parkinson's symptoms. The wire, connected to a
battery pack under the skin, electrically stimulates these small portions
of the brain and quiets the over-activity in these sites, which improves the
The study aims to determine whether the clinical benefit of deep brain stimulation
is superior to that achieved with comprehensive medication therapy and whether
the clinical benefit is maintained. The study also will compare bilateral
deep brain stimulation of two areas of the brain (globus pallidus and subthalamic
nucleus) to determine the most effective site for surgical intervention. The
findings will help to establish the optimal surgical treatment of the disabling
symptoms of Parkinson's disease.
Parkinson's disease is a slowly progressive disease of the nervous system
that causes tremors, stiffness, loss of balance and an inability to initiate
movement in people with the disorder. Approximately three-quarters to one
million people in the United States are affected by Parkinson's disease, which
has no cure. The majority of patients who begin medication therapy to control
their symptoms will either develop side effects related to the medications
or their symptoms will not be adequately controlled.
"There are some estimates that up to 70 percent of patients, over five
or 10 years, will become refractory to 'best medical therapy,' meaning that
their medication will cease to work," Follett said. "So we know
that there is a huge population of patients who need something more because
the medications are just not doing the job."
Advances in surgical techniques, including stereotactic neurosurgery, have
increased the precision and safety of brain surgery and have led to a resurgent
interest in using surgery to treat Parkinson's disease. Deep brain stimulation,
which is non-destructive and reversible, is a particularly promising surgical
The study will enroll 316 patients over two years. Initially, study participants
will be randomly assigned to one of two groups. One group will immediately
receive deep brain stimulation and the other group will receive six months
of best medication therapy and then receive deep brain stimulation.
"At six months, the condition of the patients receiving best medication
therapy will be compared to the condition of the patients who received deep
brain stimulation," Follett said. "This will give us a direct head-to-head
comparison of medication therapy and surgical treatment."
The study also will investigate whether the site of deep brain stimulation
affects the outcome for the patient. All of the participants will be randomized
to receive deep brain stimulation at one of two sites, either the globus pallidus
or the subthalamic nucleus. Participants will not know which site has been
treated until the end of the study.
Participants will be followed for two years after the surgery, at which
point the clinical effect of deep brain stimulation will be evaluated using
several measures, including scores on the Unified Parkinson's Disease Rating
Scale (UPDRS) for motor function "off" medication and "on"
stimulation. The success of deep brain stimulation in improving the quality
of patients' daily living will also be evaluated.
The UI is not one of the treatment sites. However, patients seen at the
UI or the VAMC in Iowa City who are eligible can be sent to one of the study
centers for enrollment. People age 18 and older with Parkinson's disease who
have persistent disabling symptoms despite medication therapy may be eligible
to participate in the study.
For more information about the study, please call Gatana Stoner at (319)
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