Researchers at the Ohio State University have completed a randomized, placebo-controlled, double-blind study testing the use of a transcranial magnetic stimulation (TMS) device to abort Migraine with aura. The findings of their study were presented at the 48th Annual Scientific Meeting of the American Headache Society (AHS) on June 23, 2006.
The device:
The TMS device, as shown above, is about the size of a blow dryer. At the first
sign of a migraine, it's held to the back of the head for 30 seconds and
provides two brief, painless magnetic pulses. Overactive neurons are present in
the brains of Migraineurs. When a trigger is encountered, those neurons fire in
a wave, starting a chain reaction. The TMS device sends an electric current
through a metal coil, creating a magnetic field,
which activates nerve cells in the brain, pre-empting the electrical
hyperexcitability that is building in the brain and (theoretically) aborting the
Migraine attack. At this point, the TMS device is approved by the Food and Drug
Administration (FDA) only as an investigational device while clinical studies
are being conducted.
"We theorized that we can use TMS to administer magnetic field pulses during the aura phase to interrupt this electrical hyperexcitability and abort the migraine attack," said Dr. Mohammad. "The results are very promising but need to be confirmed by an upcoming large, randomized study."
Study Method:
- Included 52 patients, at two headache centers, who have Migraine with aura.
- 23 were treated with the TMS device; 19 were treated with a placebo device that didn't deliver a pulse.
- Patients were instructed to report to the clinic at the first sign of a Migraine. They were then treated with the device or the placebo device, depending on which group they were in.
- Patients in both groups recorded their responses during the 24-hour period after treatment.
- 50 Migraine attacks were treated; 29 with TMS, 21 with placebo.
Study results:
- 69% of Migraine attacks in the TMS group were graded by the patients as no longer painful or only mildly painful two hours after treatment.
- 48% of Migraine attacks in the placebo group were graded by the patients as no longer painful or only mildly painful two hours after treatment.
- In the TMS group, 84% of patients said they had no noise sensitivity, 64 percent reported no light sensitivity and 88 percent reported no nausea.
- In the placebo group, 17% of patients said they had no noise sensitivity, 22 percent reported no light sensitivity and 56 percent reported no nausea.
- No side effects were reported by either group.
Study
conclusions:
"TMS pulses were well tolerated in this small, randomized, double-blind, "proof
of concept" study with statistically significant reductions in light and noise
sensitivity and with excellent patient-rated satisfaction marks for headache
relief without symptoms. There were strong trends to reduce pain at 2 hours,
nausea and to preserve cognition and to improve work functioning. A large
randomized trial is underway in order to confirm the findings of this novel
modality."
Summary:
While this study demonstrated interesting results, there was a significant
enough placebo response to leave me curious. It will be interesting to see that
results of the larger, multicenter trial. Subjects of this trail all had
Migraine with aura, as it's easier to recognize the beginning of a Migraine
attack and treat early. It will also be interesting to see the results of this
device on Migraine without aura.
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Sources:
Mohammad, Yousef M.; Kothari, Rashmi; Hughes, George; Nikrumah, Michael; Fischell, Scott; Fischell, Robert; Schweiger, Jill; Ruppel, Patricia. "Transcranial Magnetic Stimulation (TMS) relieves migraine headache." Platform Presentation. Los Angeles. 48th Annual Scientific Meeting of the <a target="_blank" href="http://www.americanheadachesociety.org/] American Headache Society[/link] (AHS). June 23, 2006.
Press release.
"Magnetic Device Short-Circuits Migraine Headaches, Suggests Early Research."
Los Angeles. American Headache Society. June 22, 2006.
