Status:
RECRUITING
Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology
Lead Sponsor:
Mayo Clinic
Conditions:
Chronic Headache
Nutcracker Phenomenon, Renal
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 retrogr...
Detailed Description
This is a feasibility, non-randomized, non-blinded clinical trial enrolling patients who are at least 18 years of age for the treatment of chronic headache in the setting of Nutcracker physiology with...
Eligibility Criteria
Inclusion
- Daily headache from onset lasting \> 3 months.
- Headache described as pressure sensation.
- Headache worsened in the Trendelenburg position.
- Exposed to CSF pressure/volume lowering medications.
- Tried 2 of 4 unless contraindications: acetazolamide, methazolamide, indomethacin SR or spironolactone) or CSF volume removal via LP with positive or neutral response.
- Failed at least 3 typical headache preventative medications from different classes-antidepressants, antiepileptic, blood pressure medications.
- MRI demonstrates that Nutcracker physiology is present.
- Decreased SMA angle, renal vein narrowing, decreased AMD.
- Retrograde lumbar vein flow and early EVP enhancement.
- Ability to understand study procedures and to comply with them for the entire length of the study.
- Negative pregnancy test.
Exclusion
- Evidence of disc edema.
- Positive urinalysis for hematuria or proteinuria.
- Abnormal CBC or CMP.
- MRI, MRA head and neck and MR venogram with a possible secondary causes of headache including space occupying lesions, Chiari malformation, cerebral vein thrombosis, hydrocephalus, dissection, aneurysm etc.
Key Trial Info
Start Date :
September 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT06077747
Start Date
September 17 2024
End Date
September 1 2027
Last Update
November 18 2025
Active Locations (1)
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1
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224