External trigeminal nerve stimulation (eTNS) can be an effective treatment for acute migraine even when applied well into an attack, a new study suggests.
Researchers presented the results here of a trial involving patients with migraine with or without aura with pain present at least 3 hours before treatment.
“The results of this multicenter, double-blind, randomized, sham-controlled trial demonstrate that eTNS is an effective and well-tolerated treatment for the acute treatment of migraine, offering a nonpharmacologic option for patients who may not be able to tolerate abortive medications,” Denise Chou, MD, Columbia University, New York City, told delegates here at the 18th Congress of the International Headache Society (IHC) 2017.
She described the need for nonpharmacologic migraine therapies in light of the “many contraindications and moderate to severe side effects,” of the drugs used as acute treatments. In addition, there are risks with these treatments, including headache chronification and medication overuse headache.
Supraorbital eTNS devices are already approved for the prevention of episodic migraine, and open-label safety and efficacy data showed their benefit for the acute treatment of migraine.
The aim of the current randomized, sham-controlled trial was to assess the efficacy and safety of eTNS in the acute treatment of migraine. The eTNS device delivered rectangular biphasic pulses of 16 mA (uptitrated over 14 minutes) at 100 Hz and 250 μs for 1 hour. The targets were the supratrochlearis and supraorbitalis nerves.
A sham stimulus of 1 Hz/250 μs with a maximum current of 5 mA for 1 hour provided a feeling of a paresthesia. Study patients were randomly assigned 1:1 to a single treatment with active or sham stimulation.
Participants were 18 to 65 years (mean age, about 40 years), were male or female, had a history or episodic or chronic migraine with or without aura, and were experiencing a migraine attack for at least 3 hours with stable pain intensity for at least 1 hour. They could not have taken an acute migraine medication within the past 3 hours.
The primary endpoint of the trial was the mean change in pain score at 1 hour compared with baseline. Secondary endpoints included change in pain scores at 2 hours and 24 hours from baseline and the proportion of patients who did not use pain medications at these time points.
In this analysis, Dr Chou reported on 57 patients who were evaluable for these endpoints.
At 1 hour, the active stimulus group reported a 65% decrease in pain on a visual analogue scale (VAS) compared with baseline. The sham control group reported a 32% decrease (P < .001). More patients in the active stimulus group were pain-free at all time points.