Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

4 novembre 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

74

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Massachusetts
      • Springfield, Massachusetts, Stati Uniti, 01107

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: 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.
Comparatore placebo: 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.
Droga: Saline 0.9%

A rigid endoscopic technique utilizing cotton pledget as a delivery vehicle of the topical saline allows direct visualization of the target.
Sperimentale: 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.
Droga: 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.
Comparatore placebo: 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.
Droga: Saline 0.9%

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Acute headache pain
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Headache days per month
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Additional headache symptoms
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Association of Migraine Disorders

Investigatori

  • Investigatore principale: Jerry Schreibstein, MD, Ear, Nose, & Throat Surgeons of Western New England

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 gennaio 2027

Completamento primario (Stimato)

1 settembre 2028

Completamento dello studio (Stimato)

1 gennaio 2029

Date di iscrizione allo studio

Primo inviato

1 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 agosto 2026

Primo Inserito (Effettivo)

14 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • VISION Study

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi