Transcutaneous stimulation of the trigeminal nerve has shown promise as a treatment for migraine, according to results of a randomized controlled trial.
The PREMICE (Prevention of Migraine using the STS Cefaly) trial found that daily neurostimulation for 3 months significantly reduced the number of migraines a person experienced with a magnitude of benefit similar to that reported for other preventive migraine therapies.
The trial was conducted at five headache clinics in Belgium and included 67 patients who suffered at least two migraines each month. They were randomly assigned to receive real or sham neurostimulation.
Stimulation was delivered via an electrode, known as a supraorbital transcutaneous stimulator (STS), that was placed on the forehead to cover the supratrochlear and supraorbital nerves bilaterally. Stimulation was delivered for 20 minutes every day.
By the end of the 90-day intervention, the mean number of migraine days had fallen significantly in the STS group, from 6.94 to 4.88 per month, but was unchanged in the sham treatment group.
Also, the percentage of "responders" - ie, patients with at least a 50% reduction in monthly migraine days - was significantly higher in the STS group than in the sham treatment group, at 38.1% versus 12.1%.
Three further outcome measures - monthly migraine attacks, monthly headache days, and monthly use of antimigraine drugs - were also significantly reduced in the STS group but not in the sham group.
No adverse events occurred in either group, yet compliance was modest; on average, just 61.7% of the planned stimulations were actually delivered. This is surprising given the "excellent tolerance and user-friendliness" of the STS, the authors remark.
Writing in Neurology, Jean Schoenen (Liège University, Belgium) and fellow trial investigators say that the study "provides evidence that daily treatment with an STS has a preventive effect in migraine."
They admit that the effect size "may appear small at first sight" and is not as great as that seen with topiramate, one of the most potent preventive drugs; nevertheless, the efficacy of neurostimulation is on a par with those reported for other anticonvulsants, propanolol, and behavioral therapy.
Noting that the mode of action of STS in migraine prevention is not known, the authors write: "Like occipital nerve stimulation, STS might change activity in supraspinal centers belonging to the 'pain matrix' or more specifically the 'migraine matrix,' hence increasing the 'migraine threshold.' Adequate studies are warranted to disentangle the precise mode of action."
Licensed from medwireNews with permission from Springer Healthcare Ltd. ©Springer Healthcare Ltd. All rights reserved. Neither of these parties endorse or recommend any commercial products, services, or equipment.