Real-World Evidence (RWE) Data Analysis of 1-year Consecutive Use of Remote Electrical Neuromodulation (REN)
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      This is a Post-marketing study investigating the long-term safety, utilization, and efficacy
      of REN during 12 consecutive months of using Nerivio in migraine patients.

      Safety will be assessed by the number and type of adverse events. Utilization will be
      measured by the number of monthly treatments. Efficacy will be evaluated as a change in
      headache pain severity and functional disability from baseline to 2 hours post-treatment in
      at least 50% of the treatments.
    

Detailed description: 
      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 12 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 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 specifies 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 secured, personal migraine diary, which enables patients to record and track their
      migraines and other headaches. At the beginning of each treatment, and again 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 safety and efficacy of the Nerivio treatment
      by analyzing data of patients who used the Nerivio device for consecutive 12 months (1 year):
      the following outcome will be assessed:

        1. - Safety - all adverse events that were reported within the study's period

        2. - Utilization - the number of Nerivio treatments per month

        3. - Efficacy - pain relief, freedom from pain, improvement in functional disability, and
           return to normal function (no disability) at 2 hours post-treatment

      Together, these three objectives provide a comprehensive evaluation of long-term safety
      efficacy in a large real-world dataset
    

Intervention name(s): Nerivio
Intervention type(s): Device
Intervention description(s): Remote electrical neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adults and adolescents (age > 12) who suffers from migraine who are using the Nerivio
        device for acute treatment of migraine
      
Keywords: Migraine headache; Nerivio; REN