This study showed that a novel CVS device provided effective, well-tolerated adjuvant prophylactic therapy for a group of adults with episodic migraine.
The use of novel, solid-state caloric vestibular stimulation (CVS) device significantly reduced the number of migraine days experienced by adult migraineurs, according to a new randomized, double-blind study published in Headache.1
In the study, 100 patients with episodic migraine without aura were randomly assigned to active treatment with the device or to a control placebo arm. Treatments were self-administered by patients twice daily for 3 months.* Patients were instructed to separate treatments by at least an hour. The primary endpoint of the study was the change in monthly migraine days from baseline to the third treatment month.
Patients assigned to treatment with the CVS device had a net therapeutic gain of –2.8 migraine days (P=.012) vs the control arm. At baseline, patients assigned to CVS had a median of 7.7 migraine days; that decreased to 3.9 days after 3 months of treatment. In comparison, control patients had a baseline level of 6.9 migraine days, and after 3 months, that rate decreased only by 1.1 days. In addition, patients assigned to CVS reported a decrease in the use of acute migraine medications.
No serious or unexpected adverse events were reported in either study arm.
“These results indicate that CVS therapy addresses the existing need for new prophylactic therapies for episodic migraine,” Wilkinson and colleagues1 wrote. “This approach appears to be both efficacious and very well tolerated, and further clinical testing is warranted.”
*During active treatment, patients lay on a wedge pillow to help maximize the thermoconvective effect of CVS. Treatments-both active and placebo-were administered via a headset equipped with independently controlled thermoelectric devices attached to aluminum earpieces that fit inside the ear canal. During active treatment, a time-varying saw-tooth waveform was delivered.
1. Wilkinson D, Ade KK, Rogers LL, et al. Preventing episodic migraine with caloric vestibular stimulation: a randomized controlled trial. Headache. Epub 2017l June 27.