Researchers at Rush University Medical Center are testing a new treatment for migraine headaches: occipital nerve stimulation, a surgical procedure in which an implanted neurostimulator delivers electrical impulses to nerves under the skin at the base of the head at the back of the neck.
This therapy may help migraine sufferers who do not respond to other available therapies, or who cannot tolerate the side effects of existing medications.
"The purpose of the randomized, double-blinded study is to evaluate the safety and efficacy of occipital nerve stimulation as a treatment for refractory migraine headache," says Dr. Sandeep Amin, Rush study investigator and anesthesiologist who surgically implants the device in the two-visit operation.
Rush is recruiting patients through the Diamond Headache Clinic and is the only site in Illinois in the trial.
The study, known as PRISM (Precision Implantable Stimulator for Migraine), uses Boston Scientific's Precision neurostimulator with approximately 150 patients at up to 15 sites in the U.S. The implantable pulse generator will deliver electrical impulses to the occipital nerves located just under the skin at the base of the skull at the back of the neck.
The Precision device is the smallest rechargeable neurostimulator on the market today and is already approved by the FDA for spinal cord stimulation to treat chronic pain.
There are more than 28 million migraine sufferers in the U.S., and up to 10 percent of these patients may not respond to existing treatments.
"Occipital nerve stimulation has the potential to provide relief to the large population of migraine sufferers who currently have no other medical treatments available to them that bring them relief," said Amin. "If effective, the implantable neurostimulator would provide a new treatment option to free these patients from their long-standing headache pain."
The smallest rechargeable neurostimulator available, the Precision device has been used in the treatment of more than 6,000 patients suffering from chronic pain, according to Boston Scientific.
The Precision neurostimulator is currently FDA approved for spinal cord to treat chronic pain by precisely delivering tiny electrical signals to the spinal cord that mask the perception of pain. Spinal cord stimulation is prescribed for patients with chronic pain in the limbs, trunk and back.
Migraine sufferers are monitored and complete a month-long pain diary as the first part of the study. Patients then undergo a two-part operation in which thin electrode leads are placed under the skin at the back of the neck.
A week later, the patient returns for the 45 minute procedure in which the neurostimulator is placed on one side in the lowest part of the back, and the leads are connected and the device activated. Patients then return to the neurologist for monitoring of their headaches.
During the first 3 months after the Precision neurostimulator is implanted, two different stimulation settings will be tried in different groups of patients. One group of patients is programmed to settings more likely to show a response, while the control group of patients is programmed to settings rather unlikely to be effective.
After the first three months, the control group of patients will have their devices programmed to the stimulation settings more likely to show a response.
Individuals interested in learning more about the trial can call (888) 352-7874.
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