RECRUITING

Efficacy of Nerve Blocks for Episodic Migraine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Efficacy of Peripheral Nerve Blocks for Episodic Migraine Treatment and Prophylaxis

Quick Facts

Study Start:2023-07-10

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05734625

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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)	* 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.

Inclusion Criteria

Exclusion 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)

* 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.

Contacts and Locations

Study Contact

Family Medicine Research Study Coordinators

CONTACT

507-422-6823

RSTFMSC@mayo.edu

Principal Investigator

Stephen Merry, MD, MPH

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Stephen Merry, MD, MPH, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-10

Study Completion Date2025-07

Study Record Updates

Study Start Date2023-07-10

Study Completion Date2025-07

Terms related to this study

Additional Relevant MeSH Terms

Episodic Migraine