Not yet recruiting NCT07361549
Localized Injection of Lidocaine Via the Middle Meningeal Artery for Intractable Headache Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lidocaine (drug), Saline.
- Who it may be relevant to
- Registry conditions: Refractory Migraine, Headache. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Localized Injection of Lidocaine Via the Middle Meningeal Artery for Intractable Headache Treatment: A Randomized, Double-Blinded, Parallel Phase 2 Clinical Trial
Overview
The goal of this clinical trial is to test whether injecting lidocaine into two blood vessels of the brain can help treat chronic headaches (migraines)
Interventions
- Drug Lidocaine (drug)
Intra-arterial lidocaine infusion into bilateral middle meningeal arteries - Drug Saline
Intra-arterial saline infusion into bilateral middle meningeal arteries
Primary outcome measures
- Change in Headache Impact Test-6 Scores [Time frame: From baseline to 4 week follow-up]
Eligibility criteria
Inclusion criteria
- Age 18 years or above
- Referred for diagnostic angiography
- Diagnosis of intractable migraine
- Written informed consent able to be obtained from subject
Exclusion criteria
- Baseline HIT-6 score less than 60 (severe)
- Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Concomitant intracranial pathology (eg, intracranial malignancy)
- Known hypersensitivity and/or contraindication to lidocaine or local anesthetics of the amide type
- Taking chronic medications that, when co-administered with lidocaine and other local anesthetics, are at increased risk of developing methemoglobinemia (nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, acetaminophen, metoclopramide, quinine, sulfasalazine)
- Known contraindications for angiography (eg, ESRD not requiring hemodialysis). Patients with contrast allergy with be premeditated with diphenhydramine and steroids.
- Contraindication to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC)
- Concurrent participation in another research protocol for investigation of an experimental therapy
- Per DSA imaging, presence of a cerebrovascular pathology known to cause headache (eg, arteriovenous malformation, dural arteriovenous fistula)
- Per DSA imaging, presence of anastomosis or anatomical variation (eg, branches of middle meningeal artery) that could lead to increased procedural risk
- Per DSA imaging, lack of endovascular access to either middle meningeal artery, or origin of the middle meningeal artery other than from the external carotid artery
- Known or suspected inability to adhere to study protocol or protocol requirements, as per discretion of the Investigator or treating provider
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cooper University Health Care — Camden
Identifiers
NCT: NCT07361549 · 24-279