The REN device (Nerivio by Theranica, ISRAEL) is a neuromodulation device approved by the
FDA for acute and/or preventive treatment of migraine in patients 8 years old and above.
It is a wearable device applied to the upper arm. It stimulates C and Aδ noxious fibers
using a modulated, symmetrical, biphasic, square pulse with a pulse width of 400 μs,
modulated frequency of 100-120 Hz, and up to 40 mA output current, which the patient can
adjust. The REN device is operated by a designated app that is downloaded to the user's
phone prior to first use of the Nerivio device. As part of the sign-up process for the
Nerivio app, all patients accept the terms of use, which specify that providing personal
information is done on their own free will and that their de-identified data may be used
for research purposes. Users are not obligated to provide personal information and could
treat without providing any feedback.
The app includes a secure, personal migraine diary, which enables patients to record and
track their migraines and other headaches. At the beginning of each treatment, and again
at 2 hours after the start of treatment, patients are prompted to record their symptoms,
including pain level (none, mild, moderate, severe), functional disability (None, Mild
limitation, Moderate limitation, Severe limitation), and an indication of which
medications, if any, were taken within that 2-hour time window.
Post-marketing surveillance is designed to assess the safety, utilization, and efficacy
in larger and more diverse populations and in various real-world environments and
situations. As a digital therapeutic device (i.e., electroceutical), the REN device
enables prospective collection of electronic patient-reported outcomes in real-world
clinical practice. This post-marketing RWE study investigates the impact of early
treatment (within 60 minutes from the migraine onset) vs. late treatment (over 60 minutes
from the migraine onset) on the effectiveness of the Nerivio treatment of acute migraine.
for this study, treatments were classified as 'early treatments' if Nerivcio was
administered within 1-hour (60 minutes) of migraine onset and classified as 'late
treatments' if administered more than 1-hour (60 minutes) after onset. On a patient
level, a patient was defined as an 'early-treater' if s/he had reported treatment onset
in at least two treatments and had treated early in 50% or more of treatments. A patient
was defined as a 'late-treater' if s/he had reported treatment onset in at least two
treatments and had treated late in more than 50% of treatments.
The following efficacy outcome will be assessed - Pain Relief, Pain Freedom, Functional
Disability Relief, Functional Disability Freedom, Freedom from each migraine-associated
symptom (Photophobia, Phonophobia, Nausea/Vomiting) and Consistent Efficacy.