Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      This study is intended to evaluate the efficacy and safety of Nerivio, an FDA-authorized
      remote electrical neuromodulation (REN) device for the acute treatment of migraine, for the
      acute treatment of migraine in people with chronic migraine. The device delivers
      transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation
      (CPM) that activates a descending endogenous analgesic mechanism. The study duration consists
      of a 4 weeks of active treatment with the device in about 40 patients.
    

Detailed description: 
      This open label study includes up to 2 visits. The enrollment and device training may occur
      in 2 separate visits.

      First visit - The first visit will include screening, enrollment and training on the
      application and device.

      Treatment phase - Participants will be instructed to use the device for the treatment of
      qualifying migraine headaches (see below) as soon as possible and always within 60 minutes of
      onset during a period of up to 4 weeks. Participants will be instructed to use the device
      with the intensity level identified during the device training visit (and adjust as
      necessary) and make sure the stimulation is perceptible but not painful. Participants will be
      instructed to avoid taking rescue medications within 2 hours post-treatment. If medications
      are used, participants will be instructed to record in the app when and which medication was
      taken at 2- and 24-hours post treatment. The participants will use the app to record pain
      intensity levels, the presence/absence of aura and associated migraine symptoms (nausea,
      photophobia, phonophobia, and allodynia l) as well as rate their stress level and functional
      disability at baseline, 2- and 24-hours post-treatment. At the beginning of each treatment,
      participants will also be asked to report the time elapsed from attack onset. Adverse events
      will be reported throughout this phase of the study directly to the site staff.

      Participants who do not achieve satisfactory relief at 2 hours post-treatment may treat again
      with the Nerivio™ device or may treat with usual care at that time or any time thereafter if
      the headache does not resolve. Participants will also be able to treat headache recurrence
      with the device. Migraine headaches that are not treated with the device may be treated with
      usual care.

      The first reported treatment will be considered a "training" treatment, aimed to verify that
      the participants use the device properly, and will only be included in the safety analysis.
      The efficacy evaluation will be performed on the first treatment of a qualifying attack (see
      below) following the training treatment (hereby termed "test treatment").

      Second (final) visit - End of study:

      Participants will return to the clinic following the end of the treatment phase, at which
      time they will return the device. The participants will have the option of returning the
      device by mail instead of an on-site visit.
    

Intervention name(s): Nerivio
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment