NCT05734625RecruitingPhase 2
Efficacy of Nerve Blocks for Episodic Migraine
A Randomized Trial of Bilateral Greater Occipital Nerve Blocks Versus Ten Peripheral Nerve Blocks for Acute Relief and Prophylaxis of Episodic Migraine
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
The purpose of this study is to see how well blocking two to ten of the scalp nerves (that give feeling to the scalp and are painful during migraine headaches) with bupivacaine anesthetic (numbing medication) and low dose methylprednisolone (cortisone-like medicine or steroid) work for treating and preventing migraines. Our hypothesis is that the pain of most episodic migraine headaches can be eliminated and prevented for months by blocking the nerves that give pain sensation during a migraine.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 9 Feb 2023
- Start date
- 10 Jul 2023
- Primary completion date
- Feb 2027
- Lead sponsor
- Mayo Clinic
- Diseases
- Migraine
- NCT number
- NCT05734625
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 10 Jul 2023 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Previously received peripheral nerve blocks (PNBs)
- 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
- Diagnosis of medication overuse, cervicogenic, post-traumatic, or cluster headaches or history on pre-enrollment questionnaire of cluster headache symptoms.
Other illness
- Allergy or documented contraindication to amide anesthetics (bupivacaine, lidocaine, ropivacaine, prilocaine, mepivacaine, etidocaine or levobupivacaine) or corticosteroids
- 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
- Active skin or soft tissue infection overlying injection sites
Other
- Headache in cheeks (infraorbital nerve distribution) in addition to scalp distribution.
- Currently anticoagulated
- Patients with implanted nerve stimulators or shunts
- Phobia of needles
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.