Type
Neurostimulation device
Developer
Neurolife
Application
Acute and chronic migraine
Technology
Drug-free wearable
Development Status
Approved in the US by FDA
Relivion is a non-drug, wearable neuromodulation therapy that stimulates the six branches of the occipital and trigeminal nerves, which are responsible for migraines. The therapy has demonstrated high clinical efficiency, previously only possible with invasive procedures.
In March 2021, the company Neurolife received FDA clearance for its Relivion MG external combined occipital and trigeminal neurostimulation system (eCOT-NS) neuromodulation device for acute migraine treatment. Notably, it has also received recognition as an FDA breakthrough device for the treatment of major depression.
The Relivion MG device transmits treatment information to a patient app, where the smart technology can learn about your migraine. The Relivion MG system connects information about your migraine, treatments, lifestyle and environment to your doctor via a secure cloud database to analyze data and share insights with your doctor to help optimize care.
Relivion MG is available with a prescription to people at least 18 years old.
Before using this device, talk to your doctor if you:
- Are pregnant
Are considering getting pregnant
Have heart issues
If you have any of the following, do not use the Relivion MG:
- Metal implants or shrapnel in the skull (dental implants do not count)
- Recent brain or facial trauma
- Broken skin or wounds on the forehead or base of the skull
- Implanted neurostimulators
How Does Relivion MG Work?
This is a non-invasive, self-administered neuromodulation device used for the acute treatment of migraine attacks.
The device is worn as a headset and simultaneously stimulates 6 peripheral nerve branches of the occipital (2 electrodes in the back of the head, 1 on each side over the greater occipital nerves) and trigeminal nerves (4 electrodes in the forehead, 2 on each side over the supraorbital and supratrochlear nerves).
Relivion MG is the first and only noninvasive neuromodulation device that stimulates the 2 main peripheral nerve pathways which are felt to influence migraine (trigeminal nerve pathway and occipital nerve pathway). This spread out stimulation allows for more stimulation to be delivered comfortably.
Frequently Asked Questions
Does the Relivion really work?
46% of people who used the Relivion device had pain freedom at two hours without rescue medication compared to 12% of people that used the sham device. 47% of people had resolution of pain and their most bothersome symptom (nausea, vomiting, photophobia or phonophobia) compared to 14% of people using the sham device.
Is Relivion FDA approved?
On March 2, 2021, Neurolief announced that it has received Food and Drug Administration (FDA) clearance for its Relivion® system, a non-invasive, multi-channel neuromodulation system for at home, acute treatment of migraine attacks.
What does Relivion cost?
Once a prescription is acquired, the initial fee for patients during the 90-day Relivion Therapy Program will be $200. Once the 90-day Therapy Program is concluded and you feel that Relivion is right for you, there will be several options to purchase or lease the Relivion MG device for $75/mo.
How does Relivion work?
Relivion MG is a non-invasive medical device. It transfers mild electrical pulses to branches of the Trigeminal (Supraorbital and Supratrochlear) and Occipital nerves to treat headaches.
Is there any permanent cure for migraine?
There is no cure for migraine headaches, but you can take an active role in managing them, maybe reducing how often you get them and possibly controlling how severe they are by following these tips: Keep a migraine diary.
Clinical Evidence
This FDA clearance was based on the results of a multicenter, prospective, randomized, double-blind, placebo-controlled clinical study (“RIME” study) involving 131 adult patients who treated migraine with or without aura with an hour-long acute treatment. The RIME US Pivotal Study met all its endpoints with statistical significance. The pivotal trial has been submitted along with another RCT, but neither is officially published yet. In the trial, the significant data points were:
- Complete pain freedom at 2 hours: 46% of patients in Relivion group vs. 11.8% of patients in the sham (placebo) group. 78% of patients who became pain free at 2 hours had sustained pain freedom at 24 hours. So it appears to provide a highly effective treatment for delivering pain freedom at two hours and sustained pain freedom at 24 hours.
- Freedom from the most bothersome symptom (MBS) (nausea, photophobia, or phonophobia) at 2 hours: 75% of patients in Relivion group vs. 47% of patients in the sham group. Relivion MG is the first noninvasive neuromodulation technology to be statistically positive for both pain freedom and most bothersome symptom (MBS) freedom at 2 hours.
- 76% of patients achieved headache relief at 2 hours.
Conclusion
In conclusion, the Relivion MG medical device by Neurolife presents itself as an innovative and potentially effective solution for acute migraine treatment. The device’s combination of neurostimulation and smart technology for data analysis and sharing with healthcare professionals offers a comprehensive approach to managing migraines.
The positive clinical trial results and testimonials from users provide further support for its potential to make a meaningful difference in the lives of individuals with migraines. However, like any medical treatment, it’s important for potential users to consult with their healthcare providers to determine whether this device is appropriate for their individual needs and circumstances.
References
- https://www.relivion.com/
- https://www.relivion.com/power-of-electric-brain
- https://virtualheadachespecialist.com/migraine-and-cluster-headache-neuromodulatory-devices-what-are-the-differences-do-they-really-work-and-which-is-best-for-you/
