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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine; Headache; Facial Pain or Pressure
• Intervention / Treatment: Drug: Topical solution of 4% lidocaine; Drug: Saline 0.9%

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Coorinator; Phone Number: 413-200-8634; Email: Visionstudy@migrainedisorders.org

Study Locations

• United States
  • Massachusetts
    • Springfield, Massachusetts, United States, 01107
      • Ear, Nose, & Throat Surgeons of Western New England
      • Contact: Study Coordinator; Phone Number: 413-200-8634; Email: Visionstudy@migrainedisorders.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical lidocaine endoscopically-guided intranasal nerve block; Topical solution of 4% lidocaine on small cotton pledgets with be placed endoscopically at the posterior root of the middle turbinate and in the anterior ethmoid nerve region bilaterally for Sphenopalatine Ganglion Block (SPG) block with anterior ethmoid (AE) block.	Drug: Topical solution of 4% lidocaine; A rigid endoscopic technique utilizing a cotton pledget as a delivery vehicle of the topical lidocaine allows direct visualization of the target.
Placebo Comparator: Placebo (saline) endoscopically-guided intranasal nerve block; Topical solution of saline on small cotton pledgets with be placed endoscopically at the posterior root of the middle turbinate and in the anterior ethmoid nerve region bilaterally for Sphenopalatine Ganglion Block (SPG) block with anterior ethmoid (AE) block.	Drug: Saline 0.9%; A rigid endoscopic technique utilizing cotton pledget as a delivery vehicle of the topical saline allows direct visualization of the target.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute headache pain	Acute headache pain will be measured using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible), before (pre-treatment) and after the endoscopy procedure (post-treatment) at 15, 30, 60 min and 24 hours.	Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment.
Acute facial pain or pressure	Acute facial pain or pressure will be measured using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible), before (pre-treatment) and after the endoscopy procedure (post-treatment) at 15, 30, 60 min and 24 hours.	Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment.
Acute neck pain	Acute neck pain will be measured using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible), before (pre-treatment) and after the endoscopy procedure (post-treatment) at 15, 30, 60 min and 24 hours.	Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache days per month	Daily headache pain recorded in a mobile application. Recorded as binary (Yes/No) and rated using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible).	Daily, following enrollment to right before the treatment at 1 month and again from right after the treatment to 1 month after treatment.
Facial pain or pressure days per month	Daily facial pain or pressure recorded in a mobile application. Recorded as binary (Yes/No) and rated using a 0 to 10 Likert scale (0 representing No Pain or pressure, and 10 representing the worst pain or pressure possible).	Daily, following enrollment to right before the treatment at 1 month and again from right after the treatment to 1 month after treatment.
Neck pain days per month	Daily neck pain recorded in a mobile application. Recorded as binary (Yes/No) and rated using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible).	Daily, following enrollment to right before the treatment at 1 month and again from right after the treatment to 1 month after treatment.
Sinonasal Outcome Test- 22 (SNOT-22)	SNOT-22 is A validated 22-item questionnaire that measures the health-related quality of life (HRQoL) of patients with chronic rhinosinusitis (CRS). The SNOT-22 is scored by adding the individual values of 22 symptom and quality-of-life items. Each item is graded on a scale from 0 to 5, yielding a total cumulative score between 0 and 110, where higher numbers reflect more severe symptoms and a greater impact on health.	Immediately before the treatment at 1 month and again 1 month after treatment.
Migraine Disability Assessment (MIDAS)	MIDAS is a valid and reliable short questionnaire for assessment of headache related disability. Respondents will enter the total number of days affected in the last one month for: Work or school: Days missed. Work or school productivity: Days where productivity was reduced by half or more. Household work: Days missed. Household work productivity: Days where productivity was reduced by half or more. Family, social, or leisure activities: Days missed.	Immediately before the treatment at 1 month and again 1 month after treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional headache symptoms	Additional headache symptoms recorded in a mobile application. Recorded as binary (Yes/No) and rated using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible).	Daily, following enrollment to right before the treatment at 1 month and again from right after the treatment to 1 month after treatment.
Rescue medications	Rescue medication needed, recorded in a mobile application. Recorded as binary (Yes/No).	Daily, following enrollment to right before the treatment at 1 month and again from right after the treatment to 1 month after treatment.

Collaborators and Investigators

• Sponsor: Association of Migraine Disorders
• Investigators: Principal Investigator: Jerry Schreibstein, MD, Ear, Nose, & Throat Surgeons of Western New England

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: August 1, 2026
• First Submitted That Met QC Criteria: August 10, 2026
• First Posted (Actual): August 14, 2026

Study Record Updates

• Last Update Posted (Actual): August 14, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Migraine Disorders; Headache; Facial Pain; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Lidocaine; Sodium Chloride
• Other Study ID Numbers: VISION Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No