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Preliminary Study Celebrates Positive Results for Wireless Migraine Device
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Patients with more severe migraine had even better results.
A new, wireless arm patch may be the secret to helping patients with migraine without a prescription for potentially addictive drugs.
“These results need to be confirmed with additional studies, but they are exciting,” David Yarnitsky, MD, (pictured) of Technion Faculty of Medicine in Haifa, Israel, said in a news release.
The device, developed by therapeutic electronics company Theranica, uses transcutaneous electrical stimulation to ease migraine pain. It has a patch on the armband with rubber electrodes and a chip, which blocks pain signals from making it to the brain. The wireless device can be controlled on a smartphone app.
In a double-blinded, randomized, sham-controlled trial, the team evaluated migraine data from 71 patients with episodic migraine. The participants reported 2 to 8 attacks per month and hadn’t taken preventive medication in at least two months leading up to the study.
The patients applied the skin electrodes to their upper arm quickly after a headache attack began. The device was left on for 20 minutes and put out various pulse widths during that time. The patients were asked to refrain from taking any medications for 2 hours and use the device for up to 20 migraine episodes.
There was a total of 299 treatment sessions recorded. The devices were programmed to randomly give patients one of four levels of active stimulation or a sham stimulation (placebo), which was a very low frequency. The researchers stressed that the simulation was not painful.
Out of the 71 patients, 64% experienced a 50% reduction in pain based on best of 200-ms, 150-ms, and 100-ms pulse width stimuli per patient. The 50% pain reduction was only reported in 26% of patients with the placebo stimulation.
The 43 participants who started the study with worse pain (moderate or severe) had even better results. Of those, 25 patients (58%) (66 of 134 treatments) reported having mild or no pain with the 200-ms stimulation, compared to 4 of 17 patients (24%) (8 of 29 treatments) who received placebo (P = 0.02).
In addition, 13 out of 43 patients with moderate or severe migraine pain (30%) (37 of 134 treatments) said that no pain occurred, compared to the 1 out of 17 (6%) (5 of 29 treatments) who received placebo (P = 0.004).
“These results are similar to those seen for the triptan medications for migraine,” continued Yarnitsky, who is also a member of the Medical Advisory Board for Theranica.
Applying the treatment within 20 minutes, rather than later, also resulted in more pain reduction (46.7% vs. 24.9% (P = 0.02).
One problem with the study was that during the sham stimulation, many patients stopped the treatment before the 20 minutes expired, which compromised the blindness of the trial. Regardless, the researchers are encouraged by the results from the inexpensive tool.
“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,” Yarnitsky concluded.
The study, “Nonpainful remote electrical stimulation alleviates episodic migraine pain,” was published in the journal Neurology. The news release was provided by the American Academy of Neurology.
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