Actively Recruiting
Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology
Led by Mayo Clinic · Updated on 2025-11-18
4
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research is to gather information on the safety and feasibility of coiling the lumbar vein for the treatment of chronic headaches in patients with Nutcracker physiology and retrograde lumbar vein flow with epidural venous plexus congestion. All patients are extensively evaluated by a headache trained Neurologist confirming high pressure headache refractory to other treatments.
CONDITIONS
Official Title
Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Daily headache from onset lasting > 3 months
- Headache described as pressure sensation
- Headache worsened in the Trendelenburg position
- Exposure to CSF pressure/volume lowering medications
- Tried 2 of 4 unless contraindicated: acetazolamide, methazolamide, indomethacin SR, or spironolactone, or CSF volume removal via lumbar puncture with positive or neutral response
- Failed at least 3 typical headache preventative medications from different classes, including antidepressants, antiepileptics, and blood pressure medications
- MRI shows Nutcracker physiology
- Decreased SMA angle, renal vein narrowing, decreased aortomesenteric distance
- Retrograde lumbar vein flow and early epidural venous plexus enhancement
- Ability to understand and comply with study procedures for the entire study duration
- Negative pregnancy test
You will not qualify if you...
- Evidence of disc edema
- Positive urinalysis for hematuria or proteinuria
- Abnormal complete blood count or comprehensive metabolic panel
- MRI, MRA of head and neck, and MR venogram showing possible secondary causes of headache such as space occupying lesions, Chiari malformation, cerebral vein thrombosis, hydrocephalus, dissection, aneurysm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
Research Team
J
Julia Santos
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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