NCT07054801 · Daniel Raper, MBBS
IA Lidocaine and Methylprednisolone for Headache Associated With Subarachnoid Hemorrhage
(LIMSAH)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Lidocaine hydrochloride
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.
DRUG
Methylprednisolone sodium succinate
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.
Primary outcome measures
Headache Severity
Time frame: From baseline to 12-week follow-up
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Participants who are pregnant or breastfeeding
- Conditions or concomitant medications listed in the USPI for study drugs that would compromise safety or data quality
- Current participation in another clinical trial
Where
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations