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New treatment option for Chronic Headache
Official title Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology
ClinicalTrials.gov ID: NCT06077747
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.