Blocking scalp nerves to treat episodic migraines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of blocking multiple peripheral nerves in the scalp using bupivacaine and low-dose methylprednisolone to treat and prevent episodic migraines. The hypothesis is that this approach will provide better pain relief and reduce the frequency of migraines compared to the traditional greater occipital nerve block. Participants will be monitored for headache relief, missed days of work or school, and emergency visits over a three-month period. The study aims to determine the optimal method for nerve block treatment in migraine patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Suffering from episodic migraines with and without aura occurring at least four times a month but less than 15 times a month at a severity of 5/10 pain level or greater.
* Willing to not start or stop any new medication to treat or prevent migraines during the six months of the trial.
* History fits the definition of migraine:

  * Have a history of episodic headache lasting 4-72 hours with at least 2 of the 4 following: unilateral location, pulsating/throbbing quality, moderate-severe intensity, aggravation by/causing avoidance of routine physical activity, and
  * Have a history of at least one of the following: nausea and/or vomiting, photophobia (seek out a dark room during a headache because that feels better), phonophobia (seek out a quiet environment during a headache because that feels better)

Exclusion Criteria:

* Headache in cheeks (infraorbital nerve distribution) in addition to scalp distribution.
* Women who report being currently pregnant or lactating or are of child-bearing potential or are likely to become pregnant during the medication phase and are unwilling to use a reliable form of contraception. Acceptable forms include:

  * Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
  * Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
  * Intrauterine device (IUD)
  * Total hysterectomy or tubal ligation
  * Abstinence (no sex)
* Allergy or documented contraindication to amide anesthetics (bupivacaine, lidocaine, ropivacaine, prilocaine, mepivacaine, etidocaine or levobupivacaine) or corticosteroids
* Previously received peripheral nerve blocks (PNBs)
* Currently anticoagulated
* Currently receiving Botox for migraine prophylaxis
* Started on new medication in the prior two months with known migraine-preventive efficacy or planning to start any new medication during the study
* Currently using opiate medications for pain
* History of drug or alcohol abuse within the prior two years
* Have unstable medical or surgical diseases that could impair participation in this study
* History of craniotomies, burr holes, skull fractures and/or have open skull defects
* Patients with implanted nerve stimulators or shunts
* Phobia of needles
* Active skin or soft tissue infection overlying injection sites
* Diagnosis of medication overuse, cervicogenic, post-traumatic, or cluster headaches or history on pre-enrollment questionnaire of cluster headache symptoms.

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Stephen Merry, MD, MPH — Mayo Clinic
• Study coordinator: Family Medicine Research Study Coordinators
• Email: RSTFMSC@mayo.edu
• Phone: 507-422-6823

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.