Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology
Recruiting · NCT06077747 · Interventional (participants receive a specific treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Coil Embolization of the Lumbar Vein
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed across 1 US state.
- Mayo Clinic Florida - Jacksonville, Florida, United States