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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Intra-arterial lidocaine infusion into bilateral middle meningeal arteries
Intra-arterial saline infusion into bilateral middle meningeal arteries
Cooper University Health Care
Camden, New Jersey, United States
RECRUITINGChange 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-up
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 periprocedural
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-up
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-up
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-up
Proportion with Substantial or Severe Headache Impact Test-6 Scores (1 Month)
Proportion of patients with substantial (56-59) or severe (\>= 60) Headache Impact Test-6 scores, with higher scores correlating with worser symptoms
Time frame: From baseline to 1 month follow-up
Proportion with Substantial or Severe Headache Impact Test-6 Scores (2 Months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Proportion of patients with substantial (56-59) or severe (\>= 60) Headache Impact Test-6 scores, with higher scores correlating with worser symptoms
Time frame: From baseline to 2 month follow-up
Proportion with Substantial or Severe Headache Impact Test-6 Scores (3 Months)
Proportion of patients with substantial (56-69) or severe (\>= 60) Headache Impact Test-6 scores, with higher scores correlating with worser symptoms
Time frame: From baseline to 3 month follow-up
Proportion with Low Patient Global Impression of Change Scores (Post-Treatment)
Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms
Time frame: From baseline to periprocedural
Proportion with Low Patient Global Impression of Change Scores (1 Month)
Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms
Time frame: From baseline to 1 month follow-up
Proportion with Low Patient Global Impression of Change Scores (2 Months)
Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms
Time frame: From baseline to 2 month follow-up
Proportion with Low Patient Global Impression of Change Scores (3 Months)
Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms
Time frame: From baseline to 3 month follow-up
Related or Serious Adverse Events
Incidence of related adverse events or serious adverse events
Time frame: From post-treatment to 1 week
New Stroke or All-Cause Death
Incidence of new, disabling stroke or death from any cause
Time frame: From post-treatment to 1 month follow-up