A clinical study to evaluate the efficacy and safety of Neurolief’s Relivion™ showed the wearable migraine treating headband provides significant pain reduction.
“The results of this study are promising for those seeking a non-invasive, drug-free therapy for migraine, with treated subjects receiving significant pain reduction,” 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.”
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The prospective, randomized, double-blind, parallel-group, sham controlled clinical investigation was used to secure CE Mark for the device. It evaluated the clinical performance and safety of self-administered treatment for migraine using combined occipital and trigeminal neuromodulation (Neurolief Relivion).
A total of 55 migraine sufferers were recruited for the study. They were divided into two groups: One group received neuromodulation by way of electrical stimulation and a control group received sham neuromodulation. The sham group received electrical stimulation that feels similar to the actual treatment but is inadequate to produce a clinically meaningful effect, reports Business Wire.
Two hours after initiation of treatment, 76% of the participants in the neuromodulation group experienced headache relief compared to only 31% in the control group. Additionally, 43% of treated subjects who experienced a severe or moderate level of pain before treatment reported being pain-free two hours after initiation of treatment, compared to less than 11% of subjects in the control group. No subjects reported any serious adverse events during the study.
“We are encouraged that the results of this study suggest that the Relivion, and particularly its digital therapeutics ecosystem that adapts and personalizes treatment for each patient, will soon become a disruptive neurological therapy,” said Shmuel Shany, co-founder and CEO, Neurolief. “We know that migraine sufferers are looking for 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 data will be unveiled at the American Headache Society (AHS) 2019 Annual Meeting in Philadelphia this week.
Relivion is comprised of a comfortable and adjustable electronic headset that provides precise modulated pulses simultaneously to six branches of the occipital and trigeminal nerves via several adaptive output channels around the patient’s head. The occipital and trigeminal nerves then conduct the stimulation directly 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.