“The results of this study are promising for those seeking non-invasive, drug-free migraine therapy, with subjects treated receiving significant reduction in pain” said Stewart J. Tepper MD, professor of Neurology at the Geisel School of Medicine at Dartmouth, who will present the results at AHS. “The Relivion is a comfortable, non-invasive wearable therapy that can be self-administered. More importantly, it comes without side effects or contra-indications associated with medication, targets the major neural pathways responsible for migraine pain, and can learn to deliver personalized treatment to individuals to better treat acute migraine attacks.”
To obtain CE mark for the unit, the prospective, randomized, double-blind, parallel-group, sham-controlled clinical analysis was used. Using combined occipital and trigeminal neuromodulation (Neurolief Relivion) it evaluated the clinical efficacy and safety of self-administered migraine care.
The research had recruited a total of 55 migraine sufferers. They were divided into two groups: One group received electrical stimulation neuromodulation, and one control group received sham neuromodulation. The sham group has received electrical stimulation which feels close to the actual treatment but is inadequate to produce a clinically significant effect, Business Wire reports.
Two hours after initiation of treatment, 76 percent of neuromodulation group participants experienced headache relief, compared to only 31 percent of control group participants. In addition, 43 percent of treated subjects who experienced extreme or moderate pain prior to treatment reported pain-free two hours after initiation of treatment, compared with less than 11 percent of control group subjects. No subjects reported any serious adverse events during the study.
“We are encouraged that the results of this study indicate that the Relivion will soon become a transformative neurological therapy, and especially its digital therapeutic environment that adapts and personalizes care for each patient,” said Shmuel Shany, co-founder and CEO, Neurolief. “We know that migraine sufferers seek a smart, non-invasive, drug-free way to better treat their migraine attacks, so they can get back to their lives and be productive more quickly.”
This clinical research will be revealed next week at the 2019 Annual Meeting of American Headache Society (AHS) in Philadelphia.
Relivion consists of a comfortable and adjustable electronic headset that delivers precise modulated pulses to six branches of occipital and trigeminal nerves simultaneously via several adaptive output channels around the patient’s head. The occipital and trigeminal nerves then immediately carry out the stimulus to the brainstem (Trigemino-Cervical Complex – TCC). Prior and existing non-invasive neuromodulation devices for treatment of migraine stimulate only the trigeminal nerve, treating only part of the brain that triggers migraine. In contrast, the Relivion also modulates the occipital nerves, where the majority of migraines originate. In addition, the sophisticated cloud-enabled system connects to a proprietary mobile phone app that learns over time and in the future will deliver optimized personalized treatment for each patient.