Blocking scalp nerves to treat episodic migraines
Efficacy of Peripheral Nerve Blocks for Episodic Migraine Treatment and Prophylaxis
This study is testing if blocking certain scalp nerves with a combination of medication can help people with episodic migraines feel better and have fewer headaches.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05734625 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals suffering from episodic migraines occurring 4 to 14 times a month with a pain severity of 5/10 or greater.
Not a fit: Patients with headaches primarily in the cheek area or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency and severity of episodic migraines for patients.
How similar studies have performed: Previous studies have shown some success with peripheral nerve blocks for migraines, but this specific approach of multiple nerve blocks is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rochester, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.