Real World Data Analysis: Impact of High-Frequency REN Treatments as Migraine Preventive Therapy in Adolescence
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      This is a post-marketing study investigating the safety and efficacy of the REN device
      (Nerivio by Theranica, ISRAEL) in adolescents with migraine. The data analysis will test the
      ability of Frequent use of REN for the acute treatment of migraine to reduce the number of
      monthly migraine days in subsequent months, suggesting potential preventive benefits.
    

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 of 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 to the Nerivio app, all patients accept the terms of use which
      specify that providing personal information is done by 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 (No limitation, Some limitation, Moderate
      limitation, Severe limitation), and an indication of which medications, if any, were taken
      within that 2-hour time window.

      This post-marketing RWE study investigates the potential of high usage of Nerivio for the
      acute treatment of migraine on migraine prevention, using the following outcomes:

        1. - reduction in mean monthly migraine treatment days (MMTD),

        2. - acute treatment efficacy measured 2 h post-treatment

        3. - improve in functional disability

        4. - Device safety

      Together, these objectives may provide a comprehensive evaluation of the impact of the high
      usage of Nerivio for acute treatment as a migraine preventive tool in the migraine adolescent
      population.
    

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: 
        Adolescence (age 12-18) who suffers from migraine and are using the Nerivio device for
        acute treatment of migraine.
      
Keywords: Migraine prevention; headache; Nerivio; REN