Adjunctive prophylactic noninvasive vagus nerve stimulation was more effective than was individualized standard of care alone for treatment of chronic cluster headaches in a multicenter, open-label, randomized, controlled trial, according to Dr. Charly Gaul and his associates.
In the PREVA (Prevention and Acute Treatment of Chronic Cluster Headache) trial, a group of 48 patients with chronic cluster headache (CH) received both noninvasive vagus nerve stimulation (nVNS) and standard of care consisting of individualized prophylactic medications such as verapamil, lithium, topiramate, or corticosteroids, and abortive medications such as subcutaneous sumatriptan or inhaled oxygen. A control group of 49 patients received only standard of care. Patients in the nVNS group took abortive medications only if a CH attack was not aborted within 15 minutes after stimulation. After 1 month of treatment, the nVNS group had experienced 5.9 fewer headaches per week, compared with their baseline, while the control group saw a reduction of 2.1 headaches per week from baseline.
The proportion of patients who achieved 50% or greater decline in CH attacks per week was also much higher in the nVNS group at 40%, compared with 8.3% of the control group. No serious adverse events related to treatment were reported.
“The inherent risks associated with currently available implanted neuromodulation devices and the side effects of prophylactic medications for chronic CH highlight the need for alternative therapies. To this end, nVNS serves as a safe and effective noninvasive therapy that could be easily incorporated into the existing treatment regimens of patients with chronic CH,” the investigators noted.
Find the study in Cephalalgia (doi: 10.1177/0333102415607070).
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