Nerve Blocks for Migraines
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you do not start or stop any new medication to treat or prevent migraines during the six months of the trial. If you are currently using opiate medications for pain or have started a new migraine-preventive medication in the last two months, you may not be eligible to participate.
What data supports the effectiveness of the treatment for migraines?
There is some evidence that injections near the occipital nerve with corticosteroids like methylprednisolone can help reduce the frequency and severity of cluster headaches, which are similar to migraines. However, there is no strong evidence from randomized studies to support the use of occipital nerve blocks specifically for preventing migraines.12345
Is the occipital nerve block generally safe for humans?
Occipital nerve blocks are generally considered safe, but there can be temporary side effects like facial nerve palsy, which is a temporary weakness or paralysis of the facial muscles. This side effect is rare and usually resolves within a few hours. Caution is advised when using higher concentrations of anesthetics, especially in older patients.12678
How is the treatment of nerve blocks with Methylprednisolone unique for migraines?
This treatment is unique because it involves injecting a combination of a corticosteroid (Methylprednisolone) and a local anesthetic directly into the occipital nerve area, which can provide immediate and long-lasting relief from migraine pain by targeting the precise area of pain, unlike many other treatments that have systemic effects.19101112
Research Team
Stephen Merry, MD, MPH
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for individuals who experience episodic migraines at least four times a month but less than fifteen, with pain levels of 5/10 or higher. Participants should not start or stop any migraine medications during the six-month study and must fit the specific criteria for migraine headaches. Pregnant women, those allergic to anesthetics or steroids, on certain medications like blood thinners, Botox for migraines, opiates, or have a history of substance abuse are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants maintain a headache diary for baseline data collection
Treatment
Participants receive either GONBs or MPNBs for acute migraine treatment
Follow-up
Participants are monitored for headache frequency and severity, and absenteeism
Treatment Details
Interventions
- Methylprednisolone
- Nerve Blocks
Methylprednisolone is already approved in United States, European Union, Canada for the following indications:
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor