Relivion® MG: A New Migraine Device Using “Electricity” to Rewire the Migraine Brain
This article is sponsored by Neurolief.
Have you ever wondered if there was a way to rewire the migraine brain? A new FDA cleared device called Relivion® MG is using a form of “electricity” also known as neuromodulation to stimulate two nerves involved in the migraine process. The goal of the device is to manipulate or modulate the pain pathways of the central nervous system to reduce migraine pain and suppress the migraine storm. The device works by stimulating the trigeminal nerves located above the eyes and the occipital nerves located on the back of the head with gentle electric impulses. It is the only non-invasive neuromodulation device that can stimulate two nerve pathways associated with migraine at the same time.
Over the last few years, several neuromodulation devices have received FDA clearance and become available for the acute and/or preventive treatment of migraine. Relivion® MG by Neurolief was cleared by the FDA in March 2021 for the acute treatment of migraine with and without aura in people aged 18 years and older. The device requires a prescription from a Relivion trained healthcare provider or through Relivion’s tele-health service.
How to Use the Device?
The Relivion device is used for the acute treatment of migraine attacks. Before using the device for the first time, it must be properly fitted (view instructions here.) During the onset of a headache, the device is placed on the head and worn for 20-60 minutes based on the provider’s prescription. Contrary to some other neuromodulation devices, a person can use unlimited treatments of Relivion but it is generally recommended to limit the device to 80 minutes per day. The sensation should be strong enough to relieve the head pain, but comfortable enough for prolonged treatment. For best results, it is recommended to use as needed for 8-12 weeks. For people who are receiving onabotulinumtoxinA injections, the Relivion device should not be used within 72 hours.
Side Effects
Side effects that were reported from clinical trials were mild to moderate and include scalp numbness, persistent tingling, pain, skin reaction, fatigue, sleep disruptions, dizziness and headache.
Clinical Trial Data
RIME Study1
There were 131 people in this study who were randomly given either a Relivion device (67 people) or a sham device (64 people). In medical device clinical trials, people are given a device that does not work the same as the device trying to gain FDA clearance but may feel or look similar. This is known as a sham device. A sham device is important because it helps to compare the number of people who found relief with the new treatment to see if the results are due to chance or to some other factor, also known as statistical significance.
- 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.
- 36% of people who used the Relivion device reported pain freedom at two hours and 24 hours after treatment compared to 8% of those who used the sham device.
It is important to note that people who use sham devices may still find relief, this is often caused by the attack naturally ending or due to the placebo effect.
SP-301 study2
55 people living with migraine were randomized to either the Relivion device (27 people) or the sham device (28 people).
- 76% of people who used Relivion had pain relief at 2 hours compared to 31.8% of people using the sham device.
- 78% of people who had pain freedom at 2 hours had sustained pain freedom at 24 hours.
How Can I Get a Device?
Similar to most other neuromodulation devices, Relivion requires a prescription from a healthcare provider. For best results, all healthcare providers must go through training from a device trained professional at Relivion. Once the provider receives the training, they will be considered a Certified Relivion Prescriber. You can find the list of doctors who have gone through the Relivion training here. If your doctor is not on the list of providers and you’d like to try the device then you can use Relivion’s telehealth service. The telehealth service offers people quick access to consultation. Learn more about their tele-health program here.
What Does Relivion Cost?
Currently, Relivion is offering a 90-day trial for $200. If a person chooses to discontinue the device they can return it within the 90-day trial. However, if a person wants to continue after the initial trial program, there are ways to purchase, lease or finance the device beginning at $75 per month.
When a person purchases the trial period, they will receive a 1:1 training session to teach the person how to use the device and to ensure it is set up correctly. They will be paired with a coach for the first 90 days to answer any questions and help the person along their journey with the device.
Relivion also has a free downloadable app to track treatment data which can be shared with the person’s healthcare provider.
Whats On the Horizon?
The Relivion device is currently undergoing clinical trials for migraine prevention as well as anxiety and depression. View the centers that are currently recruiting for clinical trials here.
Where Can I Learn More?
If you are interested in learning more about Relivion you can…
View frequently asked questions, click here.
References
- https://www.relivion.com/wp-content/uploads/2023/03/Tepper-SJ-et-al.-Migraine-treatment-with-eCOTNS-2022.pdf
- https://hbr.org/2016/02/a-refresher-on-statistical-significance
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9314547/
*The contents of this blog are intended for general informational purposes only and do not constitute professional medical advice, diagnosis, or treatment. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition. The writer does not recommend or endorse any specific course of treatment, products, procedures, opinions, or other information that may be mentioned. Reliance on any information provided by this content is solely at your own risk.