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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 percent of patients said they had no noise sensitivity, 64 percent
reported no light sensitivity and 88 percent reported no nausea.
- In the TMS
group, 17 percent 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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Resources:
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
American Headache Society (AHS). June 23, 2006.
Press release.
"Magnetic Device Short-Circuits Migraine Headaches, Suggests Early Research."
Los Angeles. American Headache Society. June 22, 2006.
© Teri Robert, June 30, 2006
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