Multi-Center Clinical Trial of Surgery for Parkinson's Disease
Library: MED
Keywords: PARKINSON'S DISEASE DEEP BRAIN STIMULATION CLINICAL TRIAL
Description: A University of Iowa neurosurgeon 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.



Contact: Jennifer Brown
Health Science Relations
University of Iowa
(319) 335-9917
jennifer-l-brown@uiowa.edu

IOWA CITY, Iowa -- A University of Iowa professor of neurosurgery will lead a national multi-center clinical study to compare deep brain stimuulation 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., 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 patient's symptoms.

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 procedure.

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) 353-6679.

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