A new study published in the March 1, 2017, online issue of Neurology suggests that a new wireless patch that is worn on the arm may ease migraine pain, and also reduce need for medication.
“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, which is not approved by the FDA for use in the US. “People with migraine are looking for non-drug treatments, and this new device is easy to use, has no side effects and can be conveniently used in work or social settings.”
The device uses electrical stimulation to modulate the pain signals before they reach the brain. The patch uses rubber electrodes and a computer chip placed on an armband. The device can be controlled by a smartphone app. Previous stimulation devices used to treat migraine required electrodes to be attached to the head.
The study included 71 people with episodic migraine who had two to eight attacks per month and had not taken preventive medication for migraine for at least two months. Participants applied the device to their upper arm soon after the start of a migraine and used it for 20 minutes. They did not take any medications for migraine for two hours.
The devices were programmed to randomly give either a placebo stimulation at a very low frequency, or one of four levels of active stimulation. The stimulation was designed to not be painful.
A total of 299 migraines were treated with the device during the study. With active stimulation at the three highest levels, 64 percent of people had a reduction in their pain by at least 50 percent two hours after the treatment. That compared to 26 percent of people obtaining at least 50 percent reduction from placebo stimulation.
For those who started with moderate to severe pain, their pain was reduced to mild or no pain in 58 percent of people at the highest level of stimulation, compared to 24 percent of those during the placebo stimulation. In the same group, 30 percent said they had no pain after receiving the highest level of stimulation, compared to 6 percent of those receiving the placebo stimulation.
“These results are similar to those seen for the triptan medications for migraine,” Yarnitsky said.
The researchers also found that starting the stimulation within 20 minutes of the start of a migraine was more effective, with 47 percent reducing pain when starting early, compared to 25 percent who started after 20 minutes.
Yarnitsky said one limitation of the study was that during the placebo stimulation participants often stopped the treatment before the 20-minute period was done. “This may indicate that they knew the stimulation was not active, and thus they were no longer blinded to the study, which is a challenge in any sham stimulation study,” he said.