Not yet recruitingPhase 2

Visual Instillation of Sphenopalatine-block Intervention for ONgoing Migraine

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The 2-month study requires: * One virtual visit (on the computer) * One visit to the office for placement of the numbing medicine under direct vision * Daily headache diary entries that take less than two minutes to complete"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether lidocaine, a numbing medicine placed inside the nose using a small scope, can ease migraine pain and other symptoms right away and after 24 hours. It is for adults with frequent headaches or face pain and pressure, migraine symptoms, and normal sinus scans. The 2-month study includes one video visit, one office visit, and a short daily headache diary.

The goal of this double-blinded, randomized placebo controlled clinical trial is to to see if using a numbing medicine (lidocaine) on certain areas inside the nose can help with headaches, neck pain, facial pain and pressure, and other symptoms. It also aims to understand the pathophysiology that causes these symptoms. The main questions it aims to answer are: 1. Is applying numbing medication directly to the sphenopalatine ganglion (SPG) area, while watching through the scope to make sure it's in the right place, a workable and effective way to treat migraine headaches immediately and 24 hours? 2. Is applying numbing medication directly to the sphenopalatine ganglion (SPG) area, while watching through the scope to make sure it's in the right place, a workable and effective way to improve patient-reported outcomes? The 2-month study requires: * One virtual visit (on the computer) * One visit to the office for placement of the numbing medicine under direct vision * Daily headache diary entries that take less than two minutes to complete

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older. People of any race or gender may join.
  • Have at least 2 of these migraine symptoms: light sensitivity, trouble doing daily tasks, or nausea (feeling sick to your stomach).
  • Have pain, pressure, or discomfort around the sinuses, eyes, or inside the nose for at least 3 months.
  • Have headaches or face pain or pressure on at least 10 days in a 30-day period before treatment.
  • Have a normal sinus CT or MRI scan taken while symptoms were present within the past 12 months. Certain small cysts or minor swelling are allowed.
  • If a nose scope exam was done before joining, it must show no pus-like drainage or nasal polyps (growths inside the nose).
  • Have daily access to a cell phone that can use the study app. If able to become pregnant, you must not be pregnant and must use birth control during the study.
  • Other treatments may continue and will be tracked. You will be asked to avoid medicines used to stop a headache, cannabis, and psilocybin for 24 hours before the procedure.

Who can't join

  • Had sinus surgery using a scope within the past 3 months, or have a history of a tumor at the front of the skull base.
  • Have signs of a severe infection or nasal polyps on a nose scope exam, or signs of ongoing sinus inflammation on a CT scan.
  • The study team cannot see the required areas inside your nose, including after medicine to reduce swelling.
  • Cannot tolerate numbing medicine or a nose scope exam without sedation or being put to sleep, or are allergic to lidocaine or certain related numbing medicines.
  • Currently use a Schedule II narcotic (a controlled opioid pain medicine) for migraines, or have used cocaine in the past 30 days.
  • Have a weakened immune system.
  • Have another serious or unstable health condition that the study doctor believes could make participation unsafe or interfere with the study.
  • Received an experimental treatment within 30 days before joining, or plan to take part in another clinical trial at the same time.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

MA