There's good news for those of us looking for a new acute treatment of migraine with aura. The SpringTMSâ„¢ device, developed by eNeura, was finally approved by the FDA on May 23, 2014.
As you may recall, in December, the FDA approved the Cerena Transcranial Magnetic Stimulator for the acute treatment of migraine with aura. The FDA reviewed a double-blind, placebo-controlled, randomized clinical study of 201 patients. The study, which took place in 18 U.S. centers, showed:
- Nearly 38% of subjects who used single-pulse Transcranial Magnetic Stimulation (sTMS) when they had migraine headache pain were pain-free two hours after using the device compared to approximately 17% of patients in the control group.
- After 24 hours, approximately 34% of the sTMS users were pain-free compared to only 10% in the control group.
- The treatment did not produce any device-related serious adverse events.
The SpringTMSâ„¢ device provides the same treatment as the Cerena device but offers improved portability. It's a prescription-only device that utilizes single-pulse Transcranial Magnetic Stimulation (sTMS) to induce very mild electrical currents that can depolarize neurons in the brain. This process is thought to interrupt the abnormal hyperactivity associated with migraine. The device is designed for patient use and to be as portable as possible. To use during a migraine attack, the device is placed at the back of the head where the push of a button generates a focused magnetic pulse with the intent to eliminate a migraine.
The SpringTMSâ„¢ device will not be immediately available from all doctors. It will
be launched at a select number of U.S. specialist migraine and headache centers. During this launch, an additional study of the device's efficacy will be conducted.
Comments from Migraine Specialists and Researchers:
In a press release Professor Peter Goadsby, director of the University of California San Francisco Headache Center and one of the world's leading headache and migraine experts and researchers, is quoted,
"The use of single pulse transcranial magnetic stimulation has given hundreds of patients in the U.K. relief from debilitating migraine without troublesome side effects. I am sure many migraine sufferers in the U.S. will also experience real benefits from this unique technology."
Richard B. Lipton, MD, Professor of Neurology and Director of the Montefiore Headache Center at the Albert Einstein College of Medicine, another of the world's leading headache and migraine experts and researchers, and lead investigator on the Cerena pivotal efficacy study commented,
"Many patients with migraine do not get adequate relief from available medications, prefer not to take them and sometimes overuse them. There is a great need for an effective drug-free acute treatment option for these patients. The low risk of side effects and the ease of use of the SpringTMS make it a viable option for many of my patients. I look forward to participating in the post-market observational study for this innovative technology."
In a personal interview, Dr. Lipton told me,
"People should know:
The device has been studied and is approved as an acute treatment for migraine with aura.
There is a good double blind studied published in Lancet Neurology proving that it works.
It is a great option for people who have migraine with aura and prefer or need an acute treatment option that is not a drug.
The device is very safe and often very effective.
It will be available only at certain headache centers for now including centers in It will be available only at certain headache centers for now including centers in San Francisco, New York, Philadelphia, Los Angeles, Palo Alto, and Phoenix."
In a follow-up, Dr. Lipton told me the investigators in those cities will be:
Dr. Sheena Aurora in Palo Alto,
Dr. Andrew Charles in Los Angeles,
Dr. David Dodick in Phoenix,
Dr. Peter Goadsby in San Francisco,
Dr. Richard Lipton in New York, and
Dr. Stephen Silberstein in Philadelphia.
Summary and Comments:
Although the initial launch of the SpringTMSâ„¢ device will be limited to patients at six migraine and headache clinics, the FDA approval is a huge step toward the device being made available to all patients. It's possible that one advantage for those of us who aren't patients at those centers could be that the issue of insurance coverage will be resolved during that period.
It was my pleasure to see the SpringTMSâ„¢ device at a conference a few years ago. Since it wasn't FDA approved and was to be a prescription device, I wasn't able to try it, but I can tell you that I find it amazing that it's not larger and heavier than it is.
Both the investigators of the pre-approval studies and eNeura have put years of work and dedication into bringing this device to market in the U.S. to offer American Migraine patients another treatment option. I offer them my thanks and deep appreciation.
eNeura Press Release. "eNeura, Inc. Receives FDA Clearance for SpringTMS
® Migraine Treatment Device." Baltimore, Maryland. May 23, 2014.
Interview with Dr. Richard B. Lipton. May 25, 2014.
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