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Digital therapeutic device safe, effective in acute migraine
PHILADELPHIA — A digital therapeutics device was found to be safe and effective in the treatment of acute migraine, according to a study presented at the American Headache Society Annual Scientific Meeting.
“During migraine, the product affects the brain regions which are involved in migraine and [alleviating] migraine symptoms,” Eran Schenker, MD, of George Washington University and Neurolief, Netanya, Israel, and colleagues wrote in the abstract.
“This type of therapy was previously possible only with high risk, high-cost implanted devices,” they continued. “The product provides for the first time a highly effective therapy, without the risks and costs associated with invasive procedure and without the side-effects related to medications.”
The device, Relivion (Neurolief), includes a headset with six integrated electrodes that attach to a patient’s head and send gentle signals to nerve branches in the brain affected by migraine.
Treatment with the device is self-administered by patients and managed through a smartphone app. Data from the app are collected and analyzed to optimize treatment and provide more precise, individualized therapy.
To determine the safety and efficacy of the device, researchers enrolled 55 patients in the study and randomly assigned them to a treatment or sham group. Among participants, the mean baseline pain level was 5.7 in the treatment group and 5.4 in the sham group.
Compared with the sham group, the treatment group experienced significantly decreased pain at 1 hour (group difference, 41.38%; 95% CI, 20.57-62.18), 2 hours (group difference = 32.84%; 95% CI, 2.88-62.8), and 24 hours (group difference = 36.21%; 95% CI, 5.46-66.96).
Researchers also found that the responder rate was significantly higher in the treatment group compared with the sham group at 1 hour (66.7% vs. 20%, P = .0014), 2 hours (66.7% vs. 32%, P = .0227), and 24 hours (78.3% vs. 48%, P = .0401).
Although the use of rescue medications and pain-free endpoints were not statistically different between the groups, the rate of patients pain-free at 2 hours of treatment in the treatment group (41.7%) was double that of the sham group (20%).
“The Relivion product was tested in clinical studies and confirmed safe and highly effective in treating acute migraine,” Schenker and colleagues wrote. “When used during migraine episodes the device’s clinical effectiveness was shown [to be] comparable, without adverse effects and association with medications and with no limitation on the number or duration of treatments.”– by Erin Michael
Reference:
Schenker E, et al. Digital therapeutics treatment of migraine. Presented at: American Headache Society Annual Scientific Meeting; July 11-14, 2019; Philadelphia.
Disclosures: Schenker is an employee of Neurolief.