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Sphenopalatine Ganglion Block for Chronic Daily Headache (SPG Trial)

N/A

Waitlist Available

Led By Pablo Ingelmo, MD

Research Sponsored by Pablo Ingelmo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Head injury associated with specific symptoms and/or signs

No diagnosed or strongly suspected paroxysmal hemicrania or hemicrania continua

Must not have

Current diagnose of bleeding disorder or recurrent untreated (> 3/week) nosebleeds for the past 3 months

Nasal or facial fracture impeding the use of TX360 device

Timeline

Screening 3 weeks

Treatment Varies

Follow Up asked in last visit and 1 month after last intervention again at 3 months after last intervention

Summary

This trial is testing whether a device that blocks the sphenopalatine ganglion can reduce the intensity and severity of post-traumatic headaches in adolescents.

Who is the study for?

This trial is for children and adolescents aged 10 to 17.5 with chronic daily headaches due to mild traumatic brain injury, occurring within 7 days of the injury and persisting for over 3 months. Participants must not have certain nasal deformities, severe respiratory issues, a history of serious head injuries visible on brain imaging, or allergies to local anesthetics like bupivacaine.

What is being tested?

The study tests if a transnasal sphenopalatine ganglion block can reduce headache intensity in young patients. It compares the use of saline against bupivacaine using the TX360 device and measures quality of life, headache severity, physical function, sleep quality, role function (PEDMIDAS), and adverse events.

What are the potential side effects?

Potential side effects may include discomfort or pain at the application site in the nose, minor bleeding or nasal congestion post-treatment. Allergic reactions could occur but only in those with known allergies to bupivacaine which is an exclusion criterion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a head injury with specific symptoms.

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I have not been diagnosed with or suspected to have paroxysmal hemicrania or hemicrania continua.

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I do not have any nasal or facial structure issues that would prevent the use of the TX360 device.

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My headache isn't caused by another known condition.

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My headache has lasted for more than 3 months.

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I do not have a bleeding disorder or frequent nosebleeds.

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I do not have severe breathing problems.

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I do not have angiofibroma, sinus tumors, or granuloma.

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I experience daily headaches due to a mild brain injury.

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I have never had brain bleeding or clots shown on scans due to a head injury.

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I am between 10 and 17.5 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bleeding disorder or have had frequent nosebleeds (more than 3 times a week) for the last 3 months.

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I have a broken nose or facial bone that prevents the use of certain medical devices.

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I have been diagnosed with angiofibroma, sinus tumors, or granuloma.

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I experience severe difficulty breathing, with rapid breaths or visible strain.

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I have been diagnosed with or suspected to have a specific type of headache.

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I have had a condition where my lymphocytes multiply unusually.

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I have a history of cancer.

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I have had brain bleeding or clots due to a head injury.

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I have a nasal or facial structure issue, like a cleft lip, or recent nasal surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ asked in last visit and 1 month after last intervention again at 3 months after last intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~asked in last visit and 1 month after last intervention again at 3 months after last intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and asked in last visit and 1 month after last intervention again at 3 months after last intervention for reporting.