IA Lidocaine and Methylprednisolone for Headache Associated With Subarachnoid Hemorrhage

NCT07054801 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 23-40755
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Headaches Associated With Subarachnoid Hemorrhage (SAH)

Keywords

Headache; Subarachnoid hemorrhage; Lidocaine; Methylprednisolone; Intra-arterial; Middle meningeal artery; Digital subtraction angiography

Outcome Measures

Primary Outcomes (1)

• Headache Severity

  Headache Impact Test-6 (HIT-6) score from baseline (pre-intervention) to 12 weeks postoperatively. Scores range from 36 (no impact) to 78 (severe impact), with higher scores indicating a greater negative impact.

  From baseline to 12-week follow-up

Secondary Outcomes (4)

• Headache intensity

  From baseline to 12-week follow-up

• Opioid Use

  From admission to 12-week follow-up

• Functional Outcome

  From discharge to 12-week follow-up

• Adverse Events Related to Intra-Arterial Injection

  From discharge to 12-week follow-up

Study Arms (1)

Treatment Cohort

EXPERIMENTAL

Intra-arterial 80 mg lidocaine and 40 mg methylprednisolone

Drug: Lidocaine hydrochloride; Drug: Methylprednisolone sodium succinate

Interventions

Lidocaine hydrochloride DRUG

A total of 20 mg injected in 10 mg doses will be administered over 5 min into the frontal and parietal branches of each MMA, resulting in a cumulative dose of 40 mg per MMA. The injection will be performed bilaterally, yielding a total dose of 80 mg per patient.

Also known as: Xylocaine-MPF

Treatment Cohort

Methylprednisolone sodium succinate DRUG

A total of 10 mg were injected over 5 min into the frontal and parietal branches of each MMA, resulting in a cumulative dose of 20 mg per MMA, yielding a total dose of 40 mg per patient.

Also known as: Solu-MEDROL

Treatment Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known allergy or hypersensitivity to lidocaine or amide-type anesthetics
• Known allergy or hypersensitivity to Intralipid® (intravenous fat emulsion) or any of its components, including egg phospholipids or soy-based products
• Known allergy or hypersensitivity to methylprednisolone, corticosteroids, any component of the Solu-Medrol® formulation
• Diagnostic abnormalities at baseline, including ECG abnormalities (e.g., prolonged PR/QTc intervals, heart block, arrhythmias)
• Cardiac conditions including history of heart block, Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or use of antiarrhythmics
• Steroid-induced psychiatric history; uncontrolled seizures; uncontrolled diabetes; glaucoma/ocular hypertension; current/recent high-dose systemic steroids.
• Previous IA lidocaine or methylprednisolone (or similar) therapy prior to enrollment
• Alternative headache etiology (e.g., migraines, tension-type headache)
• Unable to report pain reliably due to severe cognitive or communication deficits
• Severe hemodynamic instability precluding safe DSA participation
• Contraindications to IA catheterization or DSA (e.g., severe peripheral vascular disease, contrast allergies)
• Severe renal impairment (eGFR \<30 mL/min/1.73 m²)
• Severe hepatic impairment (e.g., Child-Pugh Class C)
• Active systemic infections
• Severe comorbid conditions with life expectancy \<30 days

Sponsors & Collaborators

• Daniel Raper, MBBS: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Headache; Subarachnoid Hemorrhage

Interventions

Lidocaine; Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Daniel Raper, MBBS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Raper, MBBS

CONTACT

408-347-4046; daniel.raper@ucsf.edu

Atakan Orscelik, MD

CONTACT

415-885-3515; atakan.orscelik@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Neurological Surgery

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)