Zapping Migraine Shows Promise - Nearing FDA Approval

Patient Expert

Portable TMS Device Shows Promise in Aborting Migraine with Aura

There's good news about abortive treatment of Migraine with aura - without medications. A portable Transcranial Magnetic Stimulation (TMS) device that is in clinical trials is showing great promise and may be FDA approved and available for use sometime this year.

Study results were presented at the 50th annual scientific meeting of American Headache Society in June. According to Richard B. Lipton, MD, Professor of Neurology at the Albert Einstein College of Medicine and study lead investigator,

"In a rigorous double blind study, TMS has been shown to be more effective than sham stimuli in the treatment of migraine with aura. TMS will provide an important treatment, particularly for people who have migraine with aura and want an effective alternative to medications."1

The TMS device is used to deliver a magnetic pulse to the brain during the aura phase of a Migraine attack. The goal is to interrupt the aura and abort the Migraine at that point, before the headache phase begins.

"Stimulation with magnetic pulses from the portable TMS device proved effective for the migraine patients... Because of the lack of adverse events in this trial and the established safety of the TMS device, this is a promising treatment for migraines with aura. This sets the stage for future studies in migraines without aura."

Dr. Yousef Mohammad neurologist, principal investigator of the study, The Ohio State University Medical Center

About the study:

Study objective: "To test the hypothesis that early treatment of migraine with aura with single pulse TMS is associated with improved headache pain outcomes."

Study Background: Prior studies had shown that TMS treatment in the clinic or doctor's office to be effective in reducing head pain in Migraineurs. These studies were performed using a large, table-top unit. These were good results, but having to treat each Migraine attack in the physician's office is hardly practical. Thus, a portable, hand-held device was developed. This study tested this hand-held device in comparison to a sham device.

Study methods:

  • This was a randomized, double-blind, parallel-group, sham-controlled study.
  • There were 201 outpatient participants enrolled in the study.
  • Participants were 18-68 years of age, with migraine with aura as defined by the International Headache Society's International Classification of Headache Disorders, 2nd Edition (ICHD-2).
  • Participants had visual aura with at least 30% of their Migraine attacks, followed by moderate or severe headache in more than 90% of their Migraine attacks.
  • The device was used by patients twice per Migraine attack, within one hour of onset of aura, while still experiencing aura.
  • Participants treated during up to 3 Migraine attacks over a period of three months.
  • Utilizing an electronic diary, participants recorded pain intensity and associated symptoms using an at the time of treatment and at 30 minutes, one hour, two hours, 24 hours and 48 hours post-treatment.
  • The primary endpoint (target result) of the study was no-pain at 2 hours for the first treated attack.

Study results: Study analysis included 164 patients...

  • Of the participants receiving the actual TMS treatment, 39 percent were pain free at the two-hour post-treatment point, compared to 22 percent in the group receiving "sham" pulses. There were no differences reported related to adverse reactions between the two groups.
  • The two-hour pain-free rates were higher with TMS (39%) than with sham
  • TMS rates of other Migraine symptoms (nausea, photophobia and phonophobia) at 2 hours were equal to or lower than sham treatment rates.
  • The number of adverse events (AEs) and number of patients experiencing AEs were similar between TMS and sham groups.
  • There were no device related serious AEs.
  • Participants receiving TMS and sham stimulation were equally likely to believe that they received TMS, indicating that they did not know which device they had used.

Study conclusion:

"These data demonstrate that early treatment of migraine with aura with TMS is associated with increased rates of freedom from pain at 2 hours in comparison with sham treatment. Given the established safety of TMS and the lack of adverse events in the trial, TMS may be a promising treatment for migraine with aura. Studies in migraine without aura should also be conducted."2

Summary and Comments:

The development of TMS devices for the treatment of Migraine is a prime example of how basic research into the cause and physiology of Migraine disease results in more and better treatment options. The old vascular theory of Migraine was that Migraine attacks begin with vasoconstriction (narrowing of the blood vessels of the brain), followed by vasodilation (widening of those blood vessels). By the late 1990s, research had shown that the vasoconstriction and dilation occurred as a result of electrical hyperexcitability in the brain.

It is anticipated that the results of the studies conducted to date may result in this portable TMS device being approved by the FDA for the treatment of Migraine as early as the end of this year.

Further studies are needed to develop a method of using this technology in the treatment of Migraine without aura.

To view a video about the device and see it in action, click the video icon to the left.


Resources:

1 Interview. Teri Robert with Richard B. Lipton, MD, Professor of Neurology at the Albert Einstein College of Medicine and study lead investigator. July 12, 2008.

2 Lipton, R.B.; Dodick, D.W.; Goadsby, P.J.; Saper, J.R.; Silberstein, S.D.; Aurora, S.K.; Mohammad, Y.M.; Ruppel, P.L.; Fischell, R.E. "Transcranial Magnetic Stimulation (TMS) Using a Portable Device is Effective for the Acute Treatment of Migraine with Aura: Results of a DoubleBlind, Sham Controlled, Randomized Study." Research presentation, 50th annual scientific meeting of American Headache Society. Boston. June 27, 2008.

3 Press release. "Portable Device Effective in Zapping Away Migraine Pain." The Ohio State University. Columbus. June 26, 2008.