A prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial involving 248 participants was used to gain FDA approval. The device activates peripheral nerves using painless, remote electrical neuromodulation, inducing a conditioned pain modulation response. The device, which is worn on the upper arm, is controlled by a smartphone app that provides users with additional benefits such as the ability to customize their treatments, receive reminders for preventive treatments, track the patterns of their headaches, and, if desired, share this data with their physicians.
