Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine
Condition: Menstrual Migraine
MeSH terms: Migraine Disorders; Premenstrual Syndrome
Study type: Observational

Summary: 
      Post-marketing, retrospective, observational survey study. Users (menstruating women only) of
      Nerivio who have used Nerivio at least 4 times between October 2019 and December 2020 will be
      contacted by email and/or through an app notification and will be asked to complete a
      5-minute online anonymous survey assessing satisfaction, effectiveness, and safety. Eligible
      users will sign an informed consent form (the consent language will appear as the first page
      of the survey, and participants will click either "agree" or "disagree" to the consent
      statement; those who click "agree" will proceed to the survey, those who click "disagree"
      will be brought to an exit page) and complete a survey asking about their satisfaction with
      Nerivio and the effectiveness and safety of the device for acute treatment of menstrual
      migraine. During the survey, participants will be screened to verify that they have menstrual
      migraine (self-reported) and have used Nerivio to treat menstrual migraines.
    

Detailed description: 
      This study aims to evaluate the safety and efficacy of Nerivio for the acute treatment of
      menstrual migraine (pure menstrual migraine or menstrually-related migraine).

      Up to 500 US-based adults aged 18-55 years old who have been prescribed the Nerivio device
      and have used it at least 4 times between October 2019 and December 2020.

      Informed consent must be obtained from the participant before any protocol-related activities
      are performed. The consent language will appear as the first page of the survey, and
      participants will click either "agree" or "disagree" to the consent statement; those who
      click "agree" will proceed to the survey, those who click "disagree" will be brought to an
      exit page.

      Users of Nerivio whose details are in the sponsor's database will be contacted by email
      (provided by the patient during the sign-up process in the Nerivio app required to use the
      device) and/or through an app notification and will be asked to complete a 5-minute online
      survey assessing satisfaction, effectiveness, and safety. Participants will sign an informed
      consent form which will appear as the first page of the survey using open-ended questions,
      multiple choice questions and Likert scales. Participants will be directed to provide honest
      opinions regarding the device use for menstrual migraine. No additional information will be
      collected, and no medical records will be used in this investigation.
    

Intervention name(s): Nerivio
Intervention type(s): Device
Intervention description(s): Nerivio Remote Electrical Neuromodulation (REN) device
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Menstruating women aged 18-55 years who have used Nerivio at least 4 times and have
        menstrual migraine.