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

4. listopadu 2026 aktualizováno: Association of Migraine Disorders

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?
  3. Does daily lidocaine nasal spray improve patient-reported outcomes?

The 3-month study requires:

  • One virtual visit (on the computer)
  • One visit to the office for placement of the numbing medicine under direct vision
  • One week of daily nasal spray treatment
  • Daily headache diary entries that take less than two minutes to complete

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

74

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: 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.
Komparátor placeba: 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.
Lék: Saline 0.9%

A rigid endoscopic technique utilizing cotton pledget as a delivery vehicle of the topical saline allows direct visualization of the target.
Experimentální: Nasal spray with lidocaine

This treatment arm will be 4% lidocaine solution in a metered bottle. The Pump size is 0.1 mL per spray dispenses 4 mg of lidocaine per spray - total of 16 mg (vol 0.4 mL). Participants will be instructed to use 2 sprays in each nostril per 24 hours.
Lék: 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.
Komparátor placeba: Nasal spray with Saline (Placebo)

This treatment arm will be saline solution in a metered bottle. The Pump size is 0.1 mL per spray dispenses 4 mg of saline per spray - total of 16 mg (vol 0.4 mL). Participants will be instructed to use 2 sprays in each nostril per 24 hours.
Lék: Saline 0.9%

A rigid endoscopic technique utilizing cotton pledget as a delivery vehicle of the topical saline allows direct visualization of the target.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Acute headache pain
Časové okno: Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment.

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
Časové okno: Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment.

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
Časové okno: Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment.

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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Headache days per month
Časové okno: Daily, following enrollment to right before the block treatment at 1 month and again from right after the treatment to 1 month after treatment. During nasal spray treatment (1 week) and 30 days following spray treatment.

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 block treatment at 1 month and again from right after the treatment to 1 month after treatment. During nasal spray treatment (1 week) and 30 days following spray treatment.
Facial pain or pressure days per month
Časové okno: Daily, following enrollment to right before the block treatment at 1 month and again from right after the treatment to 1 month after treatment. During nasal spray treatment (1 week) and 30 days following spray treatment.

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 block treatment at 1 month and again from right after the treatment to 1 month after treatment. During nasal spray treatment (1 week) and 30 days following spray treatment.
Neck pain days per month
Časové okno: Daily, following enrollment to right before the block treatment at 1 month and again from right after the treatment to 1 month after treatment. During nasal spray treatment (1 week) and 30 days following spray treatment.

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 block treatment at 1 month and again from right after the treatment to 1 month after treatment. During nasal spray treatment (1 week) and 30 days following spray treatment.
Sinonasal Outcome Test- 22 (SNOT-22)
Časové okno: Immediately before the treatment at 1 month and again 1 month after the endoscopy procedure, and again 1 month after the nasal spray treatment.

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 the endoscopy procedure, and again 1 month after the nasal spray treatment.
Migraine Disability Assessment (MIDAS)
Časové okno: Immediately before the treatment at 1 month and again 1 month after the endoscopy procedure, and again 1 month after the nasal spray treatment.

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 the endoscopy procedure, and again 1 month after the nasal spray treatment.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Additional headache symptoms
Časové okno: Daily, following enrollment to right before the block treatment at 1 month and again from right after the treatment to 1 month after treatment. During nasal spray treatment (1 week) and 30 days following spray treatment.

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 block treatment at 1 month and again from right after the treatment to 1 month after treatment. During nasal spray treatment (1 week) and 30 days following spray treatment.
Rescue medications
Časové okno: Daily, following enrollment to right before the block treatment at 1 month and again from right after the treatment to 1 month after treatment. During nasal spray treatment (1 week) and 30 days following spray treatment.

Rescue medication needed, recorded in a mobile application. Recorded as binary (Yes/No).
Daily, following enrollment to right before the block treatment at 1 month and again from right after the treatment to 1 month after treatment. During nasal spray treatment (1 week) and 30 days following spray treatment.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Association of Migraine Disorders

Vyšetřovatelé

  • Vrchní vyšetřovatel: Jerry Schreibstein, MD, Ear, Nose, & Throat Surgeons of Western New England

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. ledna 2027

Primární dokončení (Odhadovaný)

1. září 2028

Dokončení studie (Odhadovaný)

1. ledna 2029

Termíny zápisu do studia

První předloženo

1. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

10. srpna 2026

První zveřejněno (Aktuální)

14. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

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