A noninvasive device that electrically stimulates the trigeminal nerve prevented migraines for patients whose episodes were not well controlled by medication alone, a trial showed.
The number of days with a migraine dropped significantly by about two per month in the supraorbital transcutaneous stimulation group, without a change in the sham control group, Jean Schoenen, MD, PhD, of Belgium’s Liège University, and colleagues found.
While the difference between the two didn’t reach statistical significance, the coprimary endpoint showed three times more responders with at least a 50% drop in migraine days with neurostimulation (38% versus 12%, P=0.023), the group reported in the Feb. 19 issue of Neurology.
“The therapeutic gain (26%) is within the range of those reported for other preventive drug and nondrug anti-migraine treatments,” they wrote.
An accompanying editorial called for further study due to some issues with the trial, particularly whether blinding was good enough.
The 16 mA electrical pulses delivered by the device at 60 Hz intervals would be easy to feel if patients touched the electrodes whereas the 1 mA-, 1 Hz-sham stimuli “would be barely noticeable,” noted Eishi Asano, MD, PhD, of Wayne State University in Detroit, and Peter J. Goadsby, MD, PhD, of the University of California San Francisco.
“Taken together, this study has provided Class III evidence that neurostimulation with this device is effective and safe as a preventive therapy for migraine,” they concluded.
The PREMICE trial (Prevention of Migraine using the STS Cefaly) randomized 67 adults with at least two migraine attacks per month, regardless of aura, at five Belgian tertiary headache clinics to wear the sham or real device for 20 minutes daily for 3 months.
The Cefaly device consists of an eye glasses-style band with a self-adhesive electrode above the bridge of the nose covering the supratrochlear and supraorbital branches of the trigeminal nerve.
In an attempt to minimize unblinding, patients weren’t asked what the stimulation with their device felt like, weren’t enrolled if they were acquainted with another participant, and were kept from contact with each other during office visits so they wouldn’t have a chance to compare.
The sham group had a 20% drop in migraine days in the first month of treatment, similar to the active treatment group, but that effect disappeared thereafter.
By month 3, the mean number of migraine days in the neurostimulation group had fallen 30% to an average of 4.88 versus 6.94 per month during the run-in phase (P=0.023).
The average showed no change in the control group (6.54 versus 6.22 days per month, P=0.608).
“That the reduction in migraine days after effective supraorbital transcutaneous stimulation treatment just failed to reach the level of significance compared to sham stimulation may be due to the fact that the study was powered for responder rates, not for reduction in migraine days,” the researchers suggested.
Results didn’t differ by migraine aura status.
Among the secondary endpoints, significant advantages of neurostimulation versus sham were:
- Fewer monthly migraine attacks (19% versus 4% decline)
- Fewer days per month with any headache (33% versus 4% reduction)
- Lower monthly intake of acute anti-migraine drugs (-37% versus +1%)
By comparison, the migraine prevention drug topiramate (Topamax) reduced monthly migraine days by 44% and monthly migraine attacks by 48%, with a 50% responder rate of 45% across its clinical trials.
Responder rates for other anticonvulsants, propranolol (Inderal), and behavioral therapy are in the same range as for the neurostimulation device.
“Since supraorbital transcutaneous stimulation therapy seems to be effective and well tolerated, it can be combined with drug treatments without risking cumulative adverse effects,” Schoenen’s group pointed out.
No adverse events or side effects occurred in either group.
The researchers acknowledged partial unblinding as a potential limitation of the study, as well as the younger age and shorter duration of migraine in the treatment group.