Localized Injection of Lidocaine Via the Middle Meningeal Artery for Headache Treatment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaniel A Tonetti, MD
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or above
Diagnosis of chronic migraine
Referred for diagnostic cerebral angiography to screen for intracranial pathology
Written informed consent able to be obtained from subject
Disqualifiers
Baseline HIT-6 score less than 50
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Lidocaine (drug)
DrugIntra-arterial lidocaine infusion into bilateral middle meningeal arteries
Saline
DrugIntra-arterial saline infusion into bilateral middle meningeal arteries
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Headache Impact Test-6 Scores (1 Month)
Difference in Headache Impact Test-6 Scores, with larger decreases in scores correlating with improvement in symptoms
Time frame
From baseline to 1 month follow-upSecondary outcomes
1
Change in Numeric Pain Scores
Difference in Numeric Pain Scores (0-10), with larger decreases in scores correlating with improvement in symptoms
Time frame
From baseline to periprocedural2
Change in Migraine Disability Assessment Scores
Difference in Migraine Disability Assessment Scores, with larger decreases in scores correlating with improvement in symptoms
Time frame
From baseline to 3 month follow-up3
Change in Headache Impact Test-6 Scores Over Time (2 Months)
Difference in Headache Impact Test-6 Scores, with larger decreases in scores correlating with improvement in symptoms
Time frame
From baseline to 2 month follow-up4
Change in Headache Impact Test-6 Scores Over Time (3 Months)
Difference in Headache Impact Test-6 Scores, with larger decreases in scores correlating with improvement in symptoms
Time frame
From baseline to 3 month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Daniel A Tonetti, MD
Lead sponsor
The Cooper Health System
Sponsor institution
SNIS Foundation
Collaborator
Stryker Neurovascular
Collaborator
Source ClinicalTrials.gov