Called Cefaly, the Belgian-made device is the first to win FDA approval for migraine prevention and is also the first transcutaneous electrical nerve stimulation (TENS) system OK’d for any type of pain prevention, as opposed to acute treatment, the agency said.
The device is battery-powered and worn around the head, with the actual TENS stimulator centered on the forehead just above the eyes. It delivers a small, steady current to trigeminal nerve branches. Patients will be instructed to use the device once daily for a maximum of 20 minutes. It is approved for adults only.
Approval was based primarily on the PREMICE trial, in which 67 adult patients were randomized to wear either the Cefaly device or a nonfunctional sham. When turned on, the device typically causes a tingling sensation, but the trial investigators sought to maintain blinding by not asking participants what it felt like and by trying to keep them from talking with each other.
Patients assigned to the real device showed a decline from baseline of about two headache days per month, compared with no change in the control group. A responder analysis showed that 38% of patients receiving stimulation had at least a 50% reduction in monthly headache days, compared with 12% of the control group.
The Cefaly device was previously approved in Europe and Canada. The device’s manufacturer, STX-Med of Herstal, Belgium, submitted results of a patient satisfaction survey conducted among more than 2,000 users in Europe, indicating that most regular users believed they had experienced “very significant improvement” and only 4% reported adverse effects.
Across the entire respondent group, including those who only used the device infrequently or not at all, 54% reported substantial improvement.
Complaints about the device included dislike of the tingling sensation, sleepiness during the treatment sessions, and headache following the sessions, the FDA said. None of the reported adverse effects were considered serious.
Numerous TENS devices are already marketed for pain treatment.