North Shore-LIJ Recruits Patients for Migraine Study
Clinical Trial Will Explore Effectiveness of Neurostimulation for Treating Migraine Headaches
February, 18, 2009 --Researchers at North Shore-LIJ’s Harvey Cushing Institutes of Neuroscience are recruiting patients to participate in a clinical research study for adults with chronic migraine headaches. The study is testing the safety and effectiveness of a therapy called peripheral nerve stimulation (PNS), which uses an implanted device in an attempt to control pain.
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Migraine in progress The Genesis® Neurostimulation System is being tested in clinical research as a therapy for helping patients with chronic migraine headache. Genesis is an investigational system that sends mild electrical pulses to the peripheral nerves in the back of the head from a device implanted in the buttock or the chest area. Illustration provided by St. Jude Medical, Inc.
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“Chronic migraine headaches can be debilitating,” said Alon Mogilner, MD, PhD, director of functional and restorative neurosurgery at North Shore University Hospital (NSUH) in Manhasset, NY “In addition to severe headache pain, patients can suffer nausea and vomiting and other symptoms that may interfere with work or school and other day-to-day activities.”
The clinical research study is being conducted with the Genesis® neurostimulator, an investigational device, developed by the St. Jude Medical Neuromodulation Division.
The Genesis device looks and operates similar to a cardiac pacemaker and is implanted in the torso. Mild electrical pulses are delivered via thin, insulated wires connected to the device, placed underneath the skin and positioned at the base of the head to stimulate the occipital nerves. The system is programmed by a clinician to provide customized stimulation to meet patient’s individual needs.
According to the National Headache Foundation, approximately 28 million Americans suffer from migraine headaches. A migraine headache is more than just a “bad headache.” The severity of each migraine can vary widely, although the headache usually begins as a dull pain that turns into a constant throbbing or pulsing sensation. Some individuals who suffer from migraine headaches also experience nausea, vomiting and sensitivity to light and noise.
“For those experiencing chronic migraines that do not respond to existing medical treatment, PNS could be a new option,” said Dr. Mogilner.
To participate in the chronic migraine study, patients must be at least age 18 years of age or older, have headaches that start in the back of the head and/or neck, have tried two migraine-specific medications that did not adequately relieve their symptoms, and have had headache symptoms for at least 15 days a month for at least three consecutive months.
NSUH was selected as one of 15 sites in the United States to participate in the clinical research study. Funding for the study is provided by St. Jude Medical, under a U.S. Food and Drug Administration (FDA) investigational device exemption (IDE).
For more information about the clinical trial or to participate, contact Maria Gillego, NP, research coordinator at North Shore-LIJ’s Harvey Cushing Institutes of Neuroscience, at 516-570-4468, or e-mail: Mgillego@nshs.edu.
Additional study information is available at www.PowerOverMigraine.com.
Media Contact:
North Shore-LIJ Betty Olt 516-465-2645 bolt@nshs.edu
St. Jude Medical Neuromodulation Denise Landry (972) 309-8085 denise.landry@sjmneuro.com