Acute and chronic migraine
Approved in the US and Europe
Nerivio® is a smartphone-controlled electroceutical device developed by Theranica Bioelectronics for the acute treatment of episodic or chronic migraine in adolescents.
The unit provides safe and effective relief from migraine pain without any side effects, which are typically seen in the use of therapeutic drugs.
The device received De Novo approval from the US Food and Drug Administration (FDA) for clinical use in May 2019. 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 persons aged 12 years and older.
Nerivio can be accessed from any licenced healthcare professional, including telemedicine systems such as Cove and UpScript, with a prescription. It can also be delivered directly to the patient’s home.
Nerivio is available to veterans through a Federal Supply Schedule (FSS) agreement signed between Theranica and the United States Department of Veterans Affairs in February 2021.
Nerivio design and features
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 and operates through a mobile application. It visually resembles a sports armband.
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.
A Nerivio unit is effective for 12 treatments, after which it can be discarded and a new device given to refill the prescription.
Nerivio mechanism of operation
Nerivio transmits weak electrical pulses on the skin for 45 minutes at a time to produce transcutaneous electrical nerve stimulation, which generates conditioned pain modulation (CPM) and inhibits migraine pain.
The treatment intensity is indicated on a scale of zero to 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 treatment can be self-administered by the patients at the onset of a migraine attack.
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 that is delivered to C-fibre nerves, which trigger 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 utilises the company’s patent-pending Maximum Effectiveness mechanism to collect and determine electromyography signals from the treated muscle.
Clinical studies on Nerivio
The FDA’s approval of the Nerivio neurostimulation device was based on a prospective, randomised, double-blind, sham-controlled, multi-centre 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 randomised on 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 headache 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.
Marketing commentary on Theranica
Theranica is an Israel-based biomedical technology company founded in 2016. The company is focused on developing wireless technology using advanced neuromodulation therapy to treat medical conditions and diseases such as migraine headaches.