Clinical Exploration of NEUROMARK System in Participants With Chronic Migraine

Korábbi kezelés

• 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 had previous head and/or neck irradiation.

Más betegség

• 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 an acute nasal or sinus infection.
• Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
• 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.

Egyéb

• Participant Must Not:
• Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or during study.
• 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 numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sinonasal cavity.
• Be pregnant.
• Be participating in another clinical research study.

• 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.