Visual Instillation of Sphenopalatine-block Intervention for ONgoing Migraine

Part of paid clinical trials in Springfield, Massachusetts.

Sponsor
Association of Migraine Disorders
Study ID
NCT07764783
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Topical solution of 4% lidocaine — DRUG
    A rigid endoscopic technique utilizing a cotton pledget as a delivery vehicle of the topical lidocaine allows direct visualization of the target.
  • Saline 0.9% — DRUG
    A rigid endoscopic technique utilizing cotton pledget as a delivery vehicle of the topical saline allows direct visualization of the target.

Study Details

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

Key Dates

First listed
Aug 14, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Acute headache pain [ Time Frame: Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ear, Nose, & Throat Surgeons of Western New EnglandSpringfieldMassachusetts01107
Study Coordinator
413-200-8634

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