Nerve Blocks for Migraines

Overseen By Family Medicine Research Study Coordinators

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Anticoagulants, Botox, Opiates, others

Disqualifiers: Pregnancy, Allergy to anesthetics, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether numbing certain scalp nerves can treat and prevent migraines. It uses bupivacaine, a numbing medication, and methylprednisolone, a steroid, to block the nerves responsible for migraine pain. The study includes two groups: one receives blocks in one main nerve, while the other receives multiple nerve blocks. Individuals who experience migraines with or without aura at least four times a month but fewer than 15, and have a pain level of 5 out of 10 or greater, may be suitable candidates. Participants must agree not to start or stop any migraine medication during the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to developing new migraine therapies.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that greater occipital nerve blocks are very safe. Many patients tolerate them well, experiencing only minor side effects. Studies have demonstrated their effectiveness in managing migraines. This procedure is commonly used for treating headaches due to its strong safety record.

Research indicates that multiple peripheral nerve blocks are generally safe as well. Most patients reported positive results, with headache relief lasting at least 24 hours, and some experienced benefits for up to six weeks. Although results vary regarding the addition of a steroid to these blocks, they remain safe and useful for treating migraines.

Overall, blocking these nerves is considered a safe way to help with migraines. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these migraine treatments because they explore nerve blocks as a potentially effective solution. Unlike typical migraine treatments that often rely on oral medications like triptans or preventive drugs, these investigational treatments directly target specific nerves associated with migraine pain. The Greater Occipital Nerve block group focuses on blocking pain in a targeted area, potentially offering quick relief. Meanwhile, the Multiple Peripheral Nerve block group involves a more comprehensive approach by blocking multiple nerves, which could reduce migraine frequency and severity. This localized, direct method could offer a new way to manage migraines, especially for those who haven't found success with pills or other systemic treatments.

What evidence suggests that these nerve block treatments could be effective for migraines?

Research has shown that injections called greater occipital nerve blocks, which participants in this trial may receive, can significantly reduce the frequency and severity of migraines. Many patients report substantial improvements, with some studies indicating a 60% decrease in headache severity and fewer migraine days. Another treatment arm in this trial involves multiple peripheral nerve blocks, which also show promising results. Many people experience noticeable relief, with 93% reporting improved headaches for at least 24 hours, and more than half feeling much better for up to 6 weeks. These injections numb certain scalp nerves that become overactive during migraines, providing both quick and lasting relief. ^{1 2 3 5 6}

Who Is on the Research Team?

Stephen Merry, MD, MPH

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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

I agree not to change my migraine medications for six months.

I have a history of migraines lasting 4-72 hours with specific symptoms.

I experience migraines 4-14 times a month with severe pain.

Exclusion Criteria

I am not pregnant, breastfeeding, or planning to become pregnant without using contraception.

You have had issues with using drugs or alcohol in the past two years.

I am allergic or cannot take certain anesthetics or corticosteroids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual or in-person)

Run-in

Participants maintain a headache diary for baseline data collection

4 weeks

Weekly electronic diary submissions

Treatment

Participants receive either GONBs or MPNBs for acute migraine treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for headache frequency and severity, and absenteeism

12 weeks

Weekly electronic diary submissions

What Are the Treatments Tested in This Trial?

Interventions

• Methylprednisolone
• Nerve Blocks

Trial Overview

The study tests if nerve blocks using bupivacaine (a numbing agent) and low-dose methylprednisolone (a steroid) can treat and prevent episodic migraines by targeting scalp nerves linked to migraine pain. The hypothesis suggests that this treatment could relieve pain and prevent future episodes for months.

How Is the Trial Designed?

Group I: Multiple Peripheral Nerve block group Experimental Treatment 2 Interventions

Subjects will receive 10 nerve blocks to include bilateral greater occipital, lesser occipital, auriculotemporal, supraorbital and supratrochlear nerves.

Group II: Greater Occipital Nerve block group Experimental Treatment 2 Interventions

Subjects will receive bilateral greater occipital nerve blocks for a total of 2 blocks

Methylprednisolone is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Medrol for:

• Allergic reactions
• Blood disorders
• Cancer
• Eye diseases
• Immune system disorders
• Inflammatory diseases
• Respiratory diseases
• Skin diseases

Approved in European Union as Depo-Medrol for:

• Allergic reactions
• Blood disorders
• Cancer
• Eye diseases
• Immune system disorders
• Inflammatory diseases
• Respiratory diseases
• Skin diseases

Approved in Canada as Solu-Medrol for:

• Allergic reactions
• Blood disorders
• Cancer
• Eye diseases
• Immune system disorders
• Inflammatory diseases
• Respiratory diseases
• Skin diseases

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Occipital nerve block (ONB) with a combination of local anesthetic and corticosteroid did not show a significant reduction in the frequency of moderate to severe migraine days compared to a placebo, with both groups having a 30% response rate.

The study involved 69 patients with episodic or chronic migraines, and the results suggest that ONB may not be an effective preventive treatment for migraines, as there was no substantial difference in outcomes between the active and placebo groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occipital nerve block for the short-term preventive treatment of migraine: A randomized, double-blinded, placebo-controlled study. Dilli, E., Halker, R., Vargas, B., et al.[2017]

Occipital nerve blocks, while generally considered safe for treating headache syndromes, can lead to rare complications such as temporary facial nerve palsy, as demonstrated in a case involving a 24-year-old woman.

The facial nerve palsy occurred shortly after the nerve block, likely due to unintended spread of the anesthetic or anatomical variations, highlighting the need for clinicians to be aware of this potential risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transient facial nerve palsy after occipital nerve block: a case report. Strauss, L., Loder, E., Rizzoli, P.[2014]

Occipital nerve blocks have been used for over 50 years in headache treatment, showing benefits for conditions like migraine, cluster headache, and postconcussive headache, primarily through case series studies.

Controlled trials indicate that combining injectable steroids with local anesthetics in occipital nerve blocks can effectively relieve cluster headache symptoms, and similar positive results were observed in trials for occipital neuralgia, which may overlap with chronic migraine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blocking the greater occipital nerve: utility in headache management. Young, WB.[2021]

In a study involving 128 patients, both Greater Occipital Nerve (GON) and Supra Orbital Nerve (SON) blocks were found to be effective in reducing migraine pain, with the GON block and the combination of GON and SON blocks providing greater pain relief compared to the SON block alone.

The results showed significant pain reduction at 120 minutes post-treatment for the GON and Combined groups, indicating that these methods are more effective than a placebo and suggest that GON blockade may be the preferred option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of greater occipital nerve and supra orbital nerve blocks methods in the treatment of acute migraine attack: A randomized double-blind controlled trial. Hokenek, NM., Ozer, D., Yılmaz, E., et al.[2022]

Occipital nerve blocks can provide immediate pain relief for occipital migraines and may lead to long-term resolution of symptoms, as demonstrated in a case report from an emergency department setting.

This targeted treatment approach contrasts with traditional migraine therapies that often have systemic effects, highlighting the potential benefits of localized interventions for migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of occipital nerve block in emergency department treatment of status migrainosus. Yanuck, J., Nelson, A., Jen, M.[2019]

The study demonstrated that a traditional landmark-based scalp block effectively targets all six major nerves responsible for scalp innervation, ensuring adequate analgesic coverage in a cadaveric model involving six unembalmed human cadavers.

However, the technique also resulted in significant unintentional spread of the local anesthetic to branches of the facial nerve, indicating a potential for broader effects than intended, which could have implications for safety and efficacy in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Anatomic Spread of Selective Nerve Scalp Blocks Using Methylene Blue: A Cadaveric Analysis. Harbell, MW., Bolton, PB., Koyyalamudi, V., et al.[2023]

In a study of 89 patients receiving occipital nerve blocks with Lidocaine, the procedure was generally safe, with only 9% experiencing adverse effects, primarily among those receiving 5% Lidocaine.

The findings suggest that while 1% Lidocaine is safe for occipital nerve blocks, caution is advised when using 5% Lidocaine, especially in elderly patients aged 70 and older, particularly when administering bilateral injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effect profile of lidocaine injections for occipital nerve block in occipital neuralgia. Sahai-Srivastava, S., Subhani, D.[2021]

In a study examining the effects of Depo-Medrol and myristyl-gamma-picolinium chloride (MGP) on rabbit visual function, Depo-Medrol did not affect the electroretinogram (ERG) or visual evoked potential (VEP), suggesting it may be safe for use in ocular injections.

In contrast, MGP at higher concentrations significantly impaired ERG responses and delayed VEP responses, indicating potential toxicity to the visual system that could last for over two months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of Depo-Medrol preservative on the rabbit visual system. Loewenstein, A., Zemel, E., Lazar, M., et al.[2018]

In a study of 16 patients with cluster headaches, an injection of 160 mg methylprednisolone into the greater occipital nerve showed mixed results, with some patients experiencing cessation or reduction in headache severity, while others did not respond at all.

Overall, the efficacy of this treatment was not as favorable as previously reported, indicating that while some patients may benefit, the response can be variable and not guaranteed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of vascular pain of the face by methylprednisolone injection into the area of the greater occipital nerve: 16 cases]. Bigo, A., Delrieu, F., Bousser, MG.[2013]

Methylprednisolone acetate (Depo-Medrol) injections via epidural or intrathecal routes can effectively relieve diskogenic back pain and radiculopathy when conservative treatments have failed, particularly if symptoms have lasted less than three months.

Corticosteroid injections are less effective for patients with chronic symptoms lasting over three months or those who have previously undergone surgery, suggesting a limited window for optimal use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of diskogenic pain using epidural and intrathecal steroids. Brown, FW.[2019]

In a randomized clinical trial involving 28 patients with acute migraines, bilateral greater occipital nerve block (GONB) with bupivacaine resulted in 31% of patients achieving headache freedom at 30 minutes, compared to 0% in the sham injection group, indicating potential efficacy for GONB in treating acute migraines.

Although the study was stopped early due to slow enrollment, the results suggest that GONB may provide sustained headache relief for 23% of patients over 48 hours, with no significant difference in side effects between the GONB and sham groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Sham-Controlled Trial of Bilateral Greater Occipital Nerve Blocks With Bupivacaine for Acute Migraine Patients Refractory to Standard Emergency Department Treatment With Metoclopramide. Friedman, BW., Mohamed, S., Robbins, MS., et al.[2019]

In a study of 190 patients with migraines, occipital nerve block demonstrated significant efficacy, with 27% of patients reporting immediate relief and 42% experiencing a reduction in pain scores to 0-2 after treatment.

The procedure was found to be safe, with only 3% of patients reporting adverse reactions, indicating that occipital nerve block can be a reliable adjunctive therapy for migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Occipital Nerve Blocks for Acute Pain Relief of Migraines. Ebied, AM., Nguyen, DT., Dang, T.[2021]

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This procedure's simplicity, safety profile, and effectiveness make the GON block essential in modern, multidisciplinary headache management. Go ...