Actively Recruiting

Phase 2
Age: 18Years - 64Years
All Genders
ID05734625

Efficacy of Peripheral Nerve Blocks for Episodic Migraine Treatment and Prophylaxis

Led by Mayo Clinic · Updated on 2026-03-06

60

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how well blocking multiple scalp nerves can treat and prevent episodic migraines. This study compares blocking only the greater occipital nerve to blocking up to ten scalp nerves using anesthetic and steroid medications. The goal is to see if targeting more nerves provides better acute headache relief and longer-lasting prevention of migraines, reducing missed work or school days and emergency visits. Participants will be randomly assigned to receive either two greater occipital nerve blocks or ten peripheral nerve blocks including greater occipital, lesser occipital, auriculotemporal, supraorbital, and supratrochlear nerves. Each nerve block involves injections of bupivacaine anesthetic mixed with methylprednisolone steroid, delivered by trained physicians. The procedures occur when participants experience a migraine of at least moderate severity. The study tracks anesthesia effectiveness and pain relief during and after the injections. During the study, participants complete baseline questionnaires and keep electronic headache diaries weekly for up to three months after treatment. Researchers measure headache pain relief shortly after nerve blocks and monitor headache frequency, severity, medication use, and impact on daily activities over time. Safety is monitored through side effect assessments. The study lasts for about four months, including a one-month run-in period and a 12-week follow-up after treatment.

CONDITIONS

Brief Title

Efficacy of Nerve Blocks for Episodic Migraine

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 64 years
  • Have episodic migraines with or without aura occurring at least 4 times but fewer than 15 times per month
  • Migraine pain severity of 5/10 or greater during attacks
  • Willing to not start or stop any new migraine treatment medication during the 6-month trial
  • History of migraine headaches lasting 4-72 hours with at least 2 of the following: unilateral pain, pulsating quality, moderate-severe intensity, or worsened by routine physical activity
  • History of at least one associated symptom: nausea/vomiting, light sensitivity, or sound sensitivity
Not Eligible

You will not qualify if you...

  • Headache pain involving cheeks or infraorbital nerve distribution
  • Women who are pregnant, breastfeeding, or of child-bearing potential and unwilling to use reliable contraception
  • Allergy or contraindication to anesthetics or corticosteroids
  • Previous peripheral nerve block treatments for migraine
  • Currently taking blood thinners
  • Receiving Botox for migraine prevention
  • Started new migraine-preventive medication in past 2 months or planning to start one during study
  • Using opioid medications for pain
  • History of drug or alcohol abuse in past 2 years
  • Unstable medical or surgical conditions
  • History of skull surgery, fractures, or open skull defects
  • Implanted nerve stimulators or shunts
  • Fear of needles
  • Active skin or soft tissue infection at injection sites
  • Diagnosis of medication overuse, cervicogenic, post-traumatic, or cluster headaches or history of cluster headache symptoms on screening questionnaire

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening visit (phone or in-person) to explain the study, validate criteria, and obtain consent

Run-in Period

Duration - 1 month

Participants complete a one-month run-in period of weekly electronic headache diaries to establish baseline headache frequency, severity, and medication use.

Weekly electronic diary entries for 4 weeks

Treatment

Duration - Single day intervention with immediate assessment

Participants receive either bilateral greater occipital nerve blocks (2 blocks) or multiple peripheral nerve blocks (up to 10 blocks) during an acute migraine episode.

1 in-person procedure visit on a weekday to receive nerve blocks and monitor pain scores for about 20 minutes after injection

Follow-up

Duration - 3 months

Participants complete weekly electronic headache diaries for 3 months after the nerve block to report headache days, pain intensity, medication use, missed activities, and healthcare visits.

Weekly electronic diary entries for 12 weeks and a questionnaire 1 day after nerve block

Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

F

Family Medicine Research Study Coordinators

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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