MigrainePhase 2VISIONNCT07764783
Visual Instillation of Sphenopalatine-block Intervention for ONgoing Migraine
A Phase 2 study testing Topical solution of 4% lidocaine and Saline 0.9% in people with Migraine and Facial Pain or Pressure, run by Association of Migraine Disorders at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Facial Pain or Pressure, Headache
- What is being tested?
- Topical solution of 4% lidocaine and Saline 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Photophobia
- Inability to function
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Ear, Nose, & Throat Surgeons of Western New England
Springfield, Massachusetts, 01107
Study Coordinator, 413-200-8634, Visionstudy@migrainedisorders.org
About this study
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:
Read more
- 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?
- 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
- Conditions
- Migraine, Facial Pain or Pressure, Headache
- Being tested
- Topical solution of 4% lidocaine, Saline 0.9%
- Medical subject headings
- Migraine Disorders, Facial Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical solution of 4% lidocaineDrug
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 group | Role | What they receive |
|---|---|---|
| Topical lidocaine endoscopically-guided intranasal nerve block | Experimental | 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. Receives: Drug: Topical solution of 4% lidocaine |
| Placebo (saline) endoscopically-guided intranasal nerve block | Placebo comparator | 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. Receives: Drug: Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment.
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Immediately before the treatment at 1 month and again 1 month after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association of Migraine Disorders
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerry Schreibstein, MD, Principal investigator, Ear, Nose, & Throat Surgeons of Western New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764783
- Sponsor's protocol ID
- VISION Study
- Acronym
- VISION
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Instillation of Sphenopalatine-block Intervention for ONgoing Migraine
- ClinicalTrials.gov ID
- NCT07764783
- Acronym / sponsor ID
- VISION / VISION Study
- Conditions
- Migraine, Facial Pain or Pressure, Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Association of Migraine DisordersUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical lidocaine endoscopically-guided intranasal nerve block | Experimental | Drug: Topical solution of 4% lidocaineTopical 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 (saline) endoscopically-guided intranasal nerve block | Placebo comparator | Drug: Saline 0.9%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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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.
Key exclusion criteria (14 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical solution of 4% lidocaineA rigid endoscopic technique utilizing a cotton pledget as a delivery vehicle of the topical lidocaine allows direct visualization of the target. | Drug | Topical lidocaine endoscopically-guided intranasal nerve block |
| Saline 0.9%A rigid endoscopic technique utilizing cotton pledget as a delivery vehicle of the topical saline allows direct visualization of the target. | Drug | Placebo (saline) endoscopically-guided intranasal nerve block |
Primary outcome
Acute headache pain
Time frame: 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.
Acute facial pain or pressure
Time frame: 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.
Acute neck pain
Time frame: 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.
5 secondary outcomes
Headache days per month
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Immediately before the treatment at 1 month and again 1 month after treatment.
Migraine Disability Assessment (MIDAS)
Time frame: Immediately before the treatment at 1 month and again 1 month after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jerry Schreibstein, MD principal investigator
Ear, Nose, & Throat Surgeons of Western New England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical solution of 4% lidocaine and Saline 0.9% in people with Migraine and Facial Pain or Pressure, run by Association of Migraine Disorders at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coorinator (413-200-8634, Visionstudy@migrainedisorders.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.