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The headset system from Neurolief was approved based on the findings of a clinical trial of 131 patients with migraine who utilized the device in treatment sessions of up to 1 hour.
Neurolief, a neurotechnology company, today announced that the FDA has cleared its noninvasive multichannel brain neuromodulation system, Relivion, for the at-home treatment of acute migraine in adults.1
The Relivion system is a headset that offers precise and personalized treatment to patients via its 3 adaptive output channels, which target 6 branches of the occipital and trigeminal nerves. This methodology in turn releases neurotransmitters in the brainstem and modulates the networks associated with pain control, the company noted.
"The clearance by the FDA of the Relivion nonsignificant risk, noninvasive neuromodulation device for acute treatment of migraine is based on several randomized controlled trials that demonstrated effectiveness for achieving freedom from pain and freedom from a patient's most bothersome symptom chosen from photophobia, phonophobia, or nausea as well as pain relief within 2 hours of treatment,” Stewart J. Tepper, MD, professor of neurology, Geisel School of Medicine, Dartmouth, told NeurologyLive. “The device combines neuromodulation of bilateral greater occipital nerves, supraorbital, and supratrochlear nerves, and this combination of inhibitory neuromodulation appears synergistic. Providers can look forward to access for another effective non-drug therapy for acute treatment of migraine."
“Patients will now have access to a highly effective, easy-to-use, non-invasive, and drug-free therapeutic option that will help them regain control of their lives,” he said in a statement.1
Tepper was the principal investigator on the pivotal international RIME trial, which included 131 patients who met the International Classification of Headache Disorders (ICHD-3) criteria of migraine with or without aura, and was the basis for the approval of Neurorelief’s system. Patients in the trial were allowed to treat several migraine attacks during the course of the trial, using the device at the onset of migraine for up to a 1-hour session.
The trial—a multi-center, prospective, randomized, double-blind, placebo-controlled clinical study—ultimately showed that 46% of those in the active treatment group achieved complete pain freedom at 2-hours post-treatment compared to only 11.8% in the control group. Pain relief was also significantly higher in the active group after 2 hours (active arm: 60%; control arm: 37%). Similarly, 75% of those in the active arm of the trial achieved complete freedom of the most bothersome symptom (MBS; defined as either phonophobia, photophobia, or nausea) within 2 hours of treatment, compared to 46.7% of those in the control group.2
As for complete freedom of migraine symptoms, defined as freedom from both pain and MBS, those treated with neuromodulation from the Relivion after 2 hours had a significantly higher percentage of patients who achieved this (47.2%) compared to the control group (11.1%). No serious adverse events were reported.
The data on 55 patients were originally presented at the American Headache Society’s 2019 annual meeting.Those data showed that following 1-hour of treatment, pain decreased significantly more in the treatment group compared to the sham group at all time points (group difference: 1 hour, 41% [P = .0002]; 2 hours, 33% [P = .03]; 24 hours, 36% [P = .02]). Additionally, ≥50% pain reduction responder rates were significantly higher in the treatment group than in the sham group after 1 hour (67% vs. 20%, respectively P = .001), 2 hours (67% vs. 32%, respectively; P = .02), and 24 hours (78% vs. 48%, respectively; P = .04).3
Relivion was previously granted a CE Mark certification in Europe as a treatment device for migraine, and is currently in preparation for the market launch, Neurolief noted. In 2020, the device received Breakthrough Device designation from the FDA for the treatment of major depressive disorder, and the company anticipates submitting an application for major depressive disorder by 2022. Other neurological and neuropsychiatric indications, including ADHD and insomnia, are also being assessed.
Neuromodulation is clinically proven to alter brain function through targeted, delivery of currents to the central nervous system. Relivion is the first non-invasive multichannel brain neuromodulation system for treating neurological and neuropsychiatric disorders," Chris Richardson, chairman, Neurolief, told NeurologyLive. "It offers precise, personalized care by delivering unparalleled stimulation to 6 branches of the occipital and trigeminal nerves via 3 adaptive output channels. This creates a cumulative effect by releasing neurotransmitters in the brainstem and modulate brain networks associated with the control of pain and mood. Effective treatment is realized without the risks and costs associated with invasive procedures and without the side effects associated with medications."
"Our Physician Interface provides a quick and simple tool for: Optimizing treatment efficacy and patient outcomes, Sending instructions to the patient for setting and adjusting the Relivion treatment regimen, Remotely Monitoring patient condition, Enhancing treatment compliance, Empowering physicians to steer treatment according to simple treatment recommendations (based on AI), Additional reimbursement for physicians," he added.