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Intra-arterial Lidocaine and Methylprednisolone Injection Into the Middle Meningeal Artery For Treatment of Headache Associated With Subarachnoid Hemorrhage

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Subarachnoid hemorrhage (SAH) is a type of bleeding around the brain that can cause sudden and severe headaches. These headaches can be debilitating and persist for weeks, significantly impacting a patient's comfort and recovery. Many patients require opioids for pain control, which can lead to side effects such as drowsiness, constipation, and dependency. There is a need for new treatment strategies to help relieve this pain while minimizing side effects. This clinical study is designed to evaluate whether an injection of two medications (lidocaine and methylprednisolone) directly into the middle meningeal artery (MMA) can help reduce headache severity in patients who recently experienced a SAH. The medications will be given through a minimally invasive procedure performed during a routine angiogram, a type of imaging test already commonly used in SAH patients. The main goals of the study are to determine whether this treatment approach is safe, helps to reduce the severity of headaches, and decreases the need for opioid pain medications. Eligible patients will be those recently diagnosed with persistent headache symptoms and SAH who are undergoing routine cerebral angiogram, during which the medications are infused into the MMA. Participants will be monitored for pain levels using the Headache Impact Test (HIT-6) and 11-point Numeric Rating Scale (NRS), and for changes in their functional recovery using standard neurologic scales. The results of this study may provide early evidence to support new treatment options for patients suffering from difficult-to-control headaches after a SAH.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults aged ≥18 years with confirmed SAH via computed tomography or magnetic resonance imaging

• Undergoing DSA as part of routine diagnostic or therapeutic care

• Experiencing headaches with baseline severity assessable using Headache Impact Test (HIT-6) questionnaire and 11-point Numeric Rating Scale (NRS)

• Conscious patients who can understand and sign informed consent form

• Hemodynamically stable and suitable for intra-arterial procedures

⁃ 5\) Willingness to comply with study procedures and follow-ups

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Daniel M S Raper, MBBS
daniel.raper@ucsf.edu
408-347-4046
Backup
Atakan Orscelik, MD
atakan.orscelik@ucsf.edu
415-353-7500
Time Frame
Start Date: 2026-06-23
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 25
Treatments
Experimental: Treatment Cohort
Intra-arterial 80 mg lidocaine and 40 mg methylprednisolone
Related Therapeutic Areas
Sponsors
Leads: Daniel Raper, MBBS

This content was sourced from clinicaltrials.gov