Clinical Exploration of NEUROMARK System in Participants With Chronic Migraine

Inclusion criteria

Participant Must:

• Be ≥18 years of age.
• Have Chronic Migraine
• Be willing and able to comply with all study elements, as indicated by written informed consent.

Exclusion criteria

Participant Must Not:

• Have diagnosis or history of complicated migraine, basilar migraine, ophthalmoplegic migraine, hemiplegic migraine, or migrainous infarction.
• Progressive neurologic disorder other than migraine.
• Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
• Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or during study.
• Have had previous sinus or nasal surgery within 6 months of study enrollment.
• Have previously undergone radiofrequency, cryotherapy, or other surgical interventions for rhinitis.
• Have started a new migraine medication regimen within 3 months of study enrollment that, according to the manufacturer's labeling, has not yet stabilized.
• Have an acute nasal or sinus infection.
• Have nasal mucosal erosion/ulceration.
• Be on prescribed anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be held for an appropriate time before the procedure.
• Have hemophilia.
• Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
• Have numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sinonasal cavity.
• Have had previous head and/or neck irradiation.
• Be pregnant.
• Have a physical, neurological, medical, psychiatric condition or situation that, in the investigator's opinion, puts the participant at risk, could confound the study results, or may interfere significantly with the participant's participation in the study.
• Be participating in another clinical research study.