Visual Instillation of Sphenopalatine-block Intervention for ONgoing Migraine (VISION)

Inclusion criteria:

• Aged 18 years or older
• Any race
• Any gender

• At least 2 of 3 positives (a, b, c) below on the ID Migraine Screener from the American Headache Society:

  1. Photophobia
  2. Inability to function
  3. Nausea
• At least 3 months of patient-reported episodic or persistent discomfort, pain, or pressure in the anatomic distribution of the paranasal sinuses, orbits, or nasal cavities.
• The patient experiences at least 10 days of headaches and/or FPP within a 30-day period, during the run-in phase.
• No evidence of abnormal sinus findings on imaging [paranasal sinus CT, including cone beam imaging, or MRI (MRI images must include all paranasal sinuses) obtained when symptomatic in the last 12 months prior to presentation. Normal imaging findings included isolated mucus retention cysts 2 cm or less in size and minimal non-circumferential (isolated areas) mucosal thickening (3mm or less).
• Normal endoscopy if performed prior to enrollment, defined as the absence of purulent (opaque - white or other discolored - secretions) at the middle meatus or sphenoethmoid recess or nasal polyp disease.
• Daily access to a cell phone that can function with the study mobile application
• For women of child bearing potential: not pregnant and using a method of contraception during the duration of the study.
• The patient can be taking interventional and preventive medications and other treatments before and during the study period, including new medications which will be tracked. The clinical coordinator will ask the patient to refrain from taking any abortive medication, cannabis, and psilocybin 24 hours prior to the procedure visit.

Exclusion criteria:

• Prior endoscopic sinus surgery within the 3 months prior to enrollment.
• Nasal endoscopy if performed prior to enrollment shows severe signs of mucosal infection, (mucopurulent drainage) or nasal polyposis.
• A history of anterior skull base neoplasia.
• Nasal endoscopy if performed prior to enrollment does not allow visualization of the middle turbinate on endoscopy bilaterally after application of a topical decongestant.
• Signs of active or chronic sinusitis on CT (>3mm mucosal thickening or air fluid level in any paranasal sinus.)
• The patient cannot tolerate the use of topical anesthetics or intranasal endoscopy without sedation or general anesthesia
• Unable to see the middle meatus with either a nasal speculum or an endoscope
• Allergy to lidocaine or other local anesthetics (tertiary amine class 1b).
• Is currently using a schedule II narcotic for migraine pain.
• Current cocaine use or cocaine use within the last 30 days.
• Currently immunocompromised
• History or evidence of any other unstable or clinically significant medical condition that in the opinion of the sponsor-investigator/ Principal Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
• Has received any investigational agent within 30 days of enrollment.
• Plans to participate in a concurrent clinical trial.