RECRUITING

Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines

Conditions

Migraine headache intervention lidocaine endovascular

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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 main purpose of this study is to evaluate the effectiveness of a new treatment in improving chronic migraine symptoms. This treatment involves a targeted lidocaine infusion into blood vessels in the skull to numb pain receptors, potentially leading to improvements in chronic migraine intensity, frequency, and duration.

Official Title

Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines

Quick Facts

Study Start:2025-03-10

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07061847

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 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adults aged 18 to 75 years with a very severe to extremely severe medically refractory Chronic Daily Headache (CDH). 1. Chronic: as defined by the International Headache Society Classification ICHD 3 (\>15 headache days a month for a period of at least 3 months) 2. Medically refractory: defined as failure of ≥3 headache preventative treatments. 3. Severely disabling (Migraine Disability Assessment \[MIDAS\] Tool score of ≥ 21 \[Grade IV\]) 4. Score of 6 (very severe) or 7 (extremely severe) on the Global Assessment of Migraine Severity (GAMS) rating scale. 5. Head pain is at least moderate-to-severe intensity (\>5 on a Visual Analog Scale) in ≥50% of headaches. 2. Diagnosis of CDH for ≥ 12 months before screening based on medical records and/or patient self-report. 3. Headache frequency: minimum 15 monthly headache days (MHD) on average across the 3 months prior to screening 4. Patient reports to their provider intolerance or insufficient response with their current preventive treatment (i.e. insufficient reduction in headache frequency, duration, and severity on a standard treatment on a generally accept therapeutic dose for 6 weeks). 5. On a stable concomitant medication and headache preventive for the 3 months prior to screening 1. Must have ≥ 15 MHD based on the patient self-maintained diary data during the baseline period. 2. Must have demonstrated \>75% compliance with diary data for the 28 day duration period, or longer if their baseline period carries on past this point. 3. Must continue to meet eligibility criteria when reassessed at baseline completion visit	1. Recently started new migraine preventative treatment regimen within the past 3 months. 2. Known allergy or sensitivity to lidocaine. 3. Lidoderm patch (not an exclusion if the Lidoderm patch has been removed for ≥ 3 days before the procedure) 4. Severe allergy/anaphylaxis to iodinated contrast dye. 5. Any intracranial pathology on brain imaging (head CT or MRI within the past 12 months) 6. Chronic subdural hematoma 7. Ischemic stroke or myocardial infarction within 3 months 8. History of renal insufficiency with Cr \> 1.5 within 3 months (will be retested during pre-surgical 9. History of abnormal ECGs within 3 months, specifically: 1. Prolonged QT syndrome 2. Use of medications that may prolong the QT interval such as: anti-nausea, anti-emetics, etc. 10. Taking any antiarrhythmic medication (other than a beta blocker) 11. Symptomatic peripheral arterial disease 12. Known inherited or acquired bleeding diathesis (not including antiplatelet or anticoagulation medication) 13. Evidence of active substance-related disorders, addictive disorders, or "recreational use" of illicit drugs. 14. Active chronic pain syndromes (e.g., fibromyalgia and chronic pelvic pain). 15. History of major psychiatric disorder or current evidence of moderately severe or severe depression based on a Patient Health Questionnaire-9 (PHQ-9) total score ≥ 15 at screening. 16. If the subject is pregnant, planning on pregnancy during the duration of the study, or planning on making their partner pregnant will be excluded from the study unless proper contraception is in place. 17. Any diagnosis at the discretion of the investigator that would make the patient unfit.

Inclusion Criteria

Exclusion Criteria

1. Adults aged 18 to 75 years with a very severe to extremely severe medically refractory Chronic Daily Headache (CDH).
1. Chronic: as defined by the International Headache Society Classification ICHD 3 (\>15 headache days a month for a period of at least 3 months)
2. Medically refractory: defined as failure of ≥3 headache preventative treatments.
3. Severely disabling (Migraine Disability Assessment \[MIDAS\] Tool score of ≥ 21 \[Grade IV\])
4. Score of 6 (very severe) or 7 (extremely severe) on the Global Assessment of Migraine Severity (GAMS) rating scale.
5. Head pain is at least moderate-to-severe intensity (\>5 on a Visual Analog Scale) in ≥50% of headaches.
2. Diagnosis of CDH for ≥ 12 months before screening based on medical records and/or patient self-report.
3. Headache frequency: minimum 15 monthly headache days (MHD) on average across the 3 months prior to screening
4. Patient reports to their provider intolerance or insufficient response with their current preventive treatment (i.e. insufficient reduction in headache frequency, duration, and severity on a standard treatment on a generally accept therapeutic dose for 6 weeks).
5. On a stable concomitant medication and headache preventive for the 3 months prior to screening
1. Must have ≥ 15 MHD based on the patient self-maintained diary data during the baseline period.
2. Must have demonstrated \>75% compliance with diary data for the 28 day duration period, or longer if their baseline period carries on past this point.
3. Must continue to meet eligibility criteria when reassessed at baseline completion visit

1. Recently started new migraine preventative treatment regimen within the past 3 months.
2. Known allergy or sensitivity to lidocaine.
3. Lidoderm patch (not an exclusion if the Lidoderm patch has been removed for ≥ 3 days before the procedure)
4. Severe allergy/anaphylaxis to iodinated contrast dye.
5. Any intracranial pathology on brain imaging (head CT or MRI within the past 12 months)
6. Chronic subdural hematoma
7. Ischemic stroke or myocardial infarction within 3 months 8. History of renal insufficiency with Cr \> 1.5 within 3 months (will be retested during pre-surgical
9. History of abnormal ECGs within 3 months, specifically:
1. Prolonged QT syndrome
2. Use of medications that may prolong the QT interval such as: anti-nausea, anti-emetics, etc.
10. Taking any antiarrhythmic medication (other than a beta blocker)
11. Symptomatic peripheral arterial disease
12. Known inherited or acquired bleeding diathesis (not including antiplatelet or anticoagulation medication)
13. Evidence of active substance-related disorders, addictive disorders, or "recreational use" of illicit drugs.
14. Active chronic pain syndromes (e.g., fibromyalgia and chronic pelvic pain).
15. History of major psychiatric disorder or current evidence of moderately severe or severe depression based on a Patient Health Questionnaire-9 (PHQ-9) total score ≥ 15 at screening.
16. If the subject is pregnant, planning on pregnancy during the duration of the study, or planning on making their partner pregnant will be excluded from the study unless proper contraception is in place.
17. Any diagnosis at the discretion of the investigator that would make the patient unfit.

Contacts and Locations

Study Contact

Jeffrey Katz, MD

CONTACT

5163257000

jkatz2@northwell.edu

Study Locations (Sites)

Neuroscience Institute at Great Neck

Great Neck, New York, 11021

United States

Collaborators and Investigators

Sponsor: Northwell Health

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 Date2025-03-10

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-03-10

Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

migraine
headache
intervention
lidocaine
endovascular

Additional Relevant MeSH Terms

Migraine