Type
Neurostimulation device
Developer
Theranica Bioelectronics
Application
Acute and chronic migraine
Technology
Drug-free wearable
Development Status
Approved in the US and Europe
Please click here to read the article for “ Tech-Enabled Migraine Relief: Wearables to the Rescue” based on extensive medical device research.
Nerivio® is a smartphone-controlled wearable neuromodulation device developed by Theranica Bioelectronics, a digital therapeutics company based in Israel, for the acute treatment of episodic or chronic migraine in adolescents.
The Nerivio device is used with a phone app and worn on the upper arm. You wear it for 45 minutes every second day to stop migraines or when a migraine starts for quick relief. It works by sending signals to nerves in the arm using Remote Electrical Neuromodulation (REN). These nerves usually tell the brain about pain. The device makes the brain react to manage pain naturally, helping to stop migraine pain without using medicine.
Nerivio is a non-invasive, drug-free, easy-to-use electronic device powered by a non-rechargeable battery. The integrated device is worn on the upper arm.
The device uses non-painful remote electrical modulation (REN) to activate peripheral nerves, inducing the internal pain management mechanism known as conditioned pain modulation (CPM) in remote body regions. It resembles a sports armband and operates through a mobile application installed on a smartphone or tablet to control and monitor the treatment and other features.
The device comprises an electronics case, firmware, mobile application software and the armband, which is equipped with electrodes covered with hydrogel.
The plastic electronics case contains an on/off switch and light-emitting diode (LED) indicator, while the mobile application software is installed and run on a smartphone or tablet. The software controls the device and allows data and records to be stored and received.
With its new dual-use indication, Nerivio is effective for 12 to 18 treatments for 45 minutes and can be used more frequently to prevent migraines proactively. Patients can choose the number of refills in the prescription included in the app.
Am I a Good Fit?
Nerivio Should be used by people who are:
- 12 years and older
- Individuals who suffer from migraines.
- Adults experiencing episodic migraine attacks.
- People seeking a non-pharmaceutical, non-invasive solution for migraine relief.
Nerivio should not be used by people with:
- Congestive heart failure
- Severe cardiac or cerebrovascular disease
- Uncontrolled epilepsy
It should only be applied on the upper arm over dry, healthy skin with normal physical sensation and without any metallic implants or in proximity to cancerous lesions. Nerivio has not been evaluated in pregnancy
Nerivio’s Mechanism of Operation
Nerivio transmits weak electrical pulses on the skin for 45 minutes at a time to produce transcutaneous electrical nerve stimulation, generating CPM to inhibit migraine pain.
The treatment intensity is indicated on a scale of 0-100 on the device’s output power. The ABORT button can be pressed to stop the treatment.
A biphasic rectangular waveform is delivered via a single channel at a modulated frequency of between 100Hz and 120Hz, with a 400µs pulse width and an output current of up to 40mA. The patients can self-administer the treatment at the onset of a migraine attack.
How do I use it?
You use it by putting the device on your upper arm and securing it with an armband—ideally, as soon as the attack starts, but it’ll still be effective within an hour of your first symptoms. You connect it to your smartphone via Bluetooth and use the free app to adjust the intensity of the treatment.
The app also includes a headache diary for migraine tracking. The treatment lasts 45 minutes, but you can go about your day while using Nerivio if you feel well enough.
Technology used in the device
Nerivio is integrated with state-of-the-art technology, including various neuromodulation and neuroscience advancements. The device’s innovative design produces a patented waveform delivered to C-fibre nerves, which triggers a pain-reducing mechanism of analgesics in the brain stem.
The company uses electrical nerve stimulation technology, neuromuscular electrical stimulation (ENS/NMES), and Bluetooth low energy. It also uses the company’s patent-pending Maximum Effectiveness mechanism to collect and determine electromyography signals from the treated muscle.
The mobile app, when integrated with Nerivio technology, allows users to tailor their migraine treatments according to patients’ needs and convenience. The software allows them to receive reminders for preventive therapies, track the patient’s migraine patterns, and optionally share migraine data with their doctor.
The application also helps users through a Guided Intervention of Education and Relaxation (GIER) using techniques such as diaphragmatic breathing, muscle relaxation, and guided imagery.
Frequently Asked Questions
Does Nerivio really work?
According to the study, Nerivio relieved migraine pain in 66% of subjects within two hours and totally relieved headache discomfort in 37%.
What is Nerivio for migraine?
The Nerivio device is worn on the upper arm and managed by a smartphone app for 45-minute therapy. During a treatment, Nerivio uses Remote Electrical Neuromodulation (REN) to stimulate nerves in the upper arm—nerves that convey pain signals to the brain.
Does Nerivio prevent migraines?
Nerivio wearable medical device received its initial FDA approval in 2019 and has subsequently shown success in migraine prevention and treatment in adolescents and adults.
How many times can I use Nerivio?
With its new dual-use indication, Nerivio is effective for 12 to 18 45-minute treatments and can be used more frequently to proactively prevent migraines. Patients can customize the amount of refills in the app’s prescription.
Where do you put Nerivio?
The Nerivio is designed for self-administration in the home. The device is worn on the upper arm and delivers transcutaneous electrical nerve stimulation (TENS) to decrease migraine discomfort by applying mild electrical pulses.
Regulatory Approvals for Nerivio
In May 2019, the Nerivio device received De Novo approval from the US Food and Drug Administration (FDA) for clinical use. The FDA classified the device as a distal transcutaneous electrical stimulator for the treatment of acute migraine.
In September 2020, Nerivio received a CE mark under the new medical device regulation (MDR) European standard for acute migraine treatment.
In January 2021, the FDA expanded the device’s indication to include the acute treatment of episodic or chronic migraine in patients aged 12 years and older. Nerivio later received FDA clearance as a dual-use acute and preventive treatment for migraines in individuals aged 12 years and older with or without aura in February 2023.
Clinical Studies on Nerivio
The FDA’s approval of the Nerivio neurostimulation device was based on a prospective randomized, double-blind, sham-controlled, multi-center clinical trial, in which 296 participants with acute migraine were enrolled. The trial was conducted at seven sites in the US and five sites in Israel.
Patients were randomized in a 1:1 ratio to receive stimulation either via the active or sham device for 30-45 minutes on the upper arm within one hour of the onset of a migraine. The sham device produced stimulation at a lower pulse width and frequency.
The study’s primary endpoint was the percentage of patients with reduced migraine headaches after two hours of treatment. Stimulation with the active device was found to be more effective than that with the sham device, with 66.7% of Nerivio patients reporting a reduction in migraine headaches compared with 38.8% of patients receiving stimulation via the sham device.
The active device was therapeutically beneficial to 27.9% of patients, while around 37.4% were pain-free after two hours of treatment. Adverse events related to the device were also low.
Conclusion
Developed by Theranica Bioelectronics, the device is intended for effective relief from migraine pain without the side effects commonly associated with therapeutic drug use.
One of the key strengths of Nerivio is its regulatory approvals. It has received authorization from the US FDA for the acute treatment of migraines in individuals aged 12 years and older, as well as the CE mark for the same indication in the EU.
Additionally, it has been recommended as a tier 2 treatment for migraines by the American Headache Society Consensus Statement.
References
- https://www.medicaldevice-network.com/projects/nerivio-treatment-migraine/#catfish
- https://www.withcove.com/learn/migraine-treatment-device-nerivio
- https://pubmed.ncbi.nlm.nih.gov/34538078/
- https://nerivio.com/reviews/
