Migraine headaches are a chronic neurological disease. Migraines affect 38 million men, women, and children in the U.S. and about 1 billion people worldwide, or about 12% of the population, according to the Migraine Research Foundation. There is no cure for migraines, but there are several medications and therapies that help reduce headache frequency or intensity for some people.
Theranica Bio-Electronics‘s Nerivio Migra is an investigational device designed to block the pain of migraine headaches. Unlike more traditional TENS (Transcutaneous Electrical Nerve Stimulation) units, the Nerivio Migra pulses are not delivered via pads located around the point of pain. Instead, the device delivers electrical impulses to the central nervous system (CNS) to activate a natural analgesic neurotransmitter in the brain. The device is placed on the outer part of the arm, just below the shoulder and above the triceps muscle. Two electrodes on the inside of the armband deliver the pulses. Pulse intensity and the length of the program are controlled by a smartphone app. Best results are obtained when the pulse intensity is set as high as possible but under the pain threshold. If the pulse intensity is sufficient, the signals travel to the brain fibers result in the release of neurotransmitters, inhibiting the pain.
Nerivio Migra has been approved as a clinical investigational device for use only in the U.S. An investigational device exemption (IDE) is granted by the FDA for clinical safety and effectiveness testing prior to clearance. If and when the device tested is deemed successful, the next step could be FDA clearance. If the Nerivio Migra is found safe and effective, it may be better compared with other e-stimulation devices because patients won’t have to apply multiple patches and run the impulse program through a separate unit attached to the patches via cables. Convenience is great, but the key question is whether or not the device brings relief to people suffering from migraines.