New pilot study finds that Theranica’s electrical stimulation device, Nerivio Migra, is able to reduce migraine pain better than sham stimulation. The device is worn on the arm.
Interviews with Brian Grosberg, MD, and Michael Marmura, MD
Electrical stimulation has shown promise in the treatment of migraines and one device worn on the forehead, the Cefaly, has been approved by the US Food and Drug Administration for the prevention of migraines.
A recently reported study has found that a second electrical stimulation (electric stim) device that is worn on the arm, rather than the head, provides significant relief during a migraine attack for some people, according to a report in Neurology.1
The pilot study used the Nerivio Migra device (Theranica, Ltd.), a wireless patch that is worn on the arm and can be controlled by a smartphone app. The device was studied in Israel in 71 people with episodic migraine, who had 2 to 8 migraine attacks per months. They were asked to apply the device to their upper arm as soon as possible after the start of a migraine and keep it on for 20 minutes (299 treatments). They were not taking any preventative medications and were told not to take any rescue medications for 2 hours after the onset of the migraine.
The devices were programmed to give either a sham stimulation, at a very low frequency, or to give an active stimulation (1 of 3 different therapeutic levels: 200-μs, 150-μs, and 100-μs pulse width stimuli per individual). The stimulation feels like a mild tingling, less noticeable than getting electrical stimulation therapy for an injury. During the active stimulation at the 3 highest levels, 64% of people had a reduction in their pain by at least 50% 2 hours after the treatment, compared to 26% of people who used the sham stimulation.
For those with moderate to severe pain, 58% said their pain was reduced to mild or no pain with the highest level of stimulation compared to 24% who received sham stimulation (30% said they had no pain, compared to 6% receiving sham stimulation). “Earlier application of the treatment, within 20 minutes of attack onset, yielded better results: 46.7% pain reduction as opposed to 24.9% reduction when started later (P = 0.02),” reported the investigators.
“These results need to be confirmed with additional studies, but they are exciting,” said study author David Yarnitsky, MD, of Technion Faculty of Medicine in Haifa, Israel, and a member of the Medical Advisory Board for Theranica, maker of the stimulation device. “People with migraine are looking for nondrug treatments, and this new device is easy to use, has no side effects and can be conveniently used in work or social settings.”
What the Experts Think
“These results nearly approximated that of a triptan,” said Brian Grosberg, MD, director of Hartford HealthCare Headache Center in Hartford, Connecticut. Dr. Grosberg is the principal investigator of a large multi-center randomized controlled trial that is now underway in an effort to seek FDA approval for the device. “It’s actually very impressive. On acute treatment, triptans probably work for 70% of migraine sufferers,” he added. No adverse events were reported in the pilot study, and treatment was well tolerated by participants.
Currently, patients can use the Cefaly device to prevent migraines, though it doesn’t work for everyone. “The data shows it is effective but the actual reduction in numbers of migraine is low and it takes a while to show effectiveness,” says Michael Marmura, MD, assistant professor, Jefferson University Hospitals in Philadelphia. “It may also reduce acute medication requirements. Although evidence suggests it works, I have questions about the effectiveness of the sham device [used in the study],” he says. “I do not tell patients to stop using other acute medications when they start Cefaly.”
“There is still a large unmet need and having an additional treatment in the armamentarium helps bridge that gap,” said Dr. Berman. This non-drug treatment would be a good option for those who don’t tolerate triptans well or get enough relief. “If it were approved, this could be used as a first line treatment, second line or used in conjunction with triptans,” he added.
How it Works
Transcutaneous electric stim delivers a series of weak electrical pulses through the skin. The treatment is based on the conditioned pain modulation (CPM) theory. By applying a “conditioning” stimulus, it influences a person’s perception of the painful (conditioned) stimulus. There are several hypotheses: Stimulus below the pain threshold activates pain inhibitory pathways, by activating large sensory fibers, which may secondarily inhibit nociceptive inputs from small fibers and raise pain thresholds.
Since the conditioning stimulus can be anywhere in the body, the electric stim device does not have to be on the head, according to the theory. In fact, for some migraine sufferers with allodynia, having stimulation on the head may trigger more pain.
- Yarnitsky D, Volokh L, Ironi A, et al. Nonpainful remote electrical stimulation alleviates episodic migraine pain. Neurology. 2017;88(13):1250-1255.