Lumbar Vein Embolization for Chronic Headaches

Overseen By Julia Santos

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: CSF pressure/volume lowering

Disqualifiers: Disc edema, Hematuria, Proteinuria, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

4 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should have tried certain medications and failed at least three typical headache preventative medications, which suggests that you may need to continue some treatments.

What data supports the effectiveness of the treatment Lumbar Vein Embolization for Chronic Headaches?

The research does not provide direct evidence for the effectiveness of lumbar vein embolization for chronic headaches, but it does mention successful use of coil embolization in treating a lumbar artery injury, suggesting potential for similar techniques in other lumbar-related conditions. ^{1 2 3 4 5}

How does the treatment Lumbar Vein Embolization for Chronic Headaches differ from other treatments for this condition?

Lumbar Vein Embolization is unique because it involves blocking blood flow in specific veins in the lower back to potentially alleviate chronic headaches, which is different from traditional treatments like epidural blood patches that address headaches caused by cerebrospinal fluid leaks. ^{3 6 7 8 9}

Research Team

Zlatko Devcic, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with chronic headaches that feel like pressure, worsen when lying back, and have been resistant to various treatments. Participants must have a specific vein condition (Nutcracker physiology) confirmed by MRI, not be pregnant, and able to follow the study's procedures. They should have tried multiple headache medications without success.

Inclusion Criteria

I understand and can follow the study's procedures.

I have taken medication to lower my CSF pressure or volume.

I have tried at least two specific treatments for my condition, or had a CSF volume removal with a positive outcome.

Exclusion Criteria

Your urine test shows blood or protein.

Your blood tests show abnormal results for your blood cells or organ function.

My MRI scans show no secondary causes for my headaches.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Multiple visits for evaluations and tests

Evaluation

Participants undergo detailed headache history, physical examination, and various tests including MRI and venography to confirm eligibility

4 weeks

Multiple visits for evaluations and tests

Treatment

Participants undergo lumbar vein embolization procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for symptom evaluation and adverse events post-procedure

18 months

1, 3, 7, 14, and 28 days after the procedure and then monthly

Treatment Details

Interventions

• Coil Embolization of the Lumbar Vein

Trial Overview The study is testing the safety of a procedure called Coil Embolization of the Lumbar Vein in patients with Nutcracker physiology who suffer from chronic headaches. The goal is to see if this treatment can relieve their symptoms.

Participant Groups

Group I: Coil embolization of lumbar vein Experimental Treatment 1 Intervention

Subjects with confirmed Nutcracker physiology, retrograde lumbar vein flow, and epidural venous plexus congestion with a high pressure headache will have coil embolization of the lumbar vein.

Coil Embolization of the Lumbar Vein is already approved in United States for the following indications:

Approved in United States as Lumbar Vein Coil Embolization for:

• Chronic headaches with Nutcracker physiology and retrograde lumbar vein flow with epidural venous plexus congestion

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

A 64-year-old patient experienced a rare but severe complication of lumbar artery injury during percutaneous endoscopic lumbar discectomy (PELD).

This case is notable as it is the first report of successfully using intraoperative angiography and coil embolization to treat such an injury, highlighting a potential new approach for managing this complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumbar Artery Injury during Transforaminal Percutaneous Endoscopic Lumbar Discectomy: Successful Treatment by Emergent Transcatheter Arterial Embolization. Wang, Y., Ai, P., Zhan, G., et al.[2018]

In a study of 16 patients with spontaneous low-pressure headaches, lumbar epidural blood patching showed that 3 patients experienced complete headache resolution, while 4 had improvements in headache intensity or frequency.

Despite the overall lower success rate compared to other studies, 5 out of 8 patients reported a significant reduction in headache severity, indicating that epidural blood patches can still provide meaningful relief for some individuals with spontaneous intracranial hypotension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of epidural blood patches for spontaneous low-pressure headaches: a case series. Ansel, S., Rae, A., Tyagi, A.[2018]

In a study of 56 patients who underwent lumbar myelograms, the presence of severe epidural contrast on postmyelogram CT scans was linked to a significantly higher risk of developing post-dural puncture headaches (PDPHs) that required treatment with an epidural blood patch (EBP), with an odds ratio of 37.00.

This finding suggests that identifying severe epidural contrast can help healthcare providers anticipate and manage potential complications, allowing for closer monitoring and timely intervention for patients at risk of PDPH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural Contrast Volume on Post-Myelogram Lumbar CT Predicts the Rate of Subsequent Blood Patch Treatment. Yu, R., Kale, H., Branstetter, BF., et al.[2021]

A 28-year-old woman developed a lumbosacral epidural hematoma after multiple lumbar punctures intended to relieve headaches from idiopathic intracranial hypertension, leading to serious complications like incomplete cauda equina syndrome.

This case underscores the rarity but potential severity of complications from lumbar punctures, suggesting that such procedures should only be performed when clearly justified, especially given the limited evidence for their long-term efficacy in headache management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple lumbar punctures aiming to relieve headache results in iatrogenic spinal hematoma: a case report. Lyons, HS., Ramalingam, S., Mitchell, JL., et al.[2022]

Cerebrospinal fluid leaks can occur in 8-25% of patients after spinal catheter insertion for intrathecal pain management, often leading to self-limiting postdural puncture headaches.

In a case study of a 49-year-old woman, persistent symptoms and wound secretion indicated a leak in the spinal catheter, which was confirmed through radiological testing; this ultimately required the removal of the entire system due to an associated infection and meningitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Spinal catheter-associated cerebrospinal fluid leak]. Welpe, P.[2018]

Lumbar epidural varicose veins can cause neurological deficits and are classified into three types based on MRI findings, highlighting the importance of accurate imaging for diagnosis.

In a case study, despite surgical intervention showing no immediate radiological change, the varicose vein completely resolved spontaneously over time, underscoring the potential for natural recovery and the need for careful monitoring through MRI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumbar Epidural Varicose Vein: Early Neurological Improvement and Late Radiological Full Recovery with Surgery; The Importance of Magnetic Resonance Imaging in Follow-Up. Celik, H., Erdem, Y., Karatay, M., et al.[2018]

In a study of 20 patients with postlumbar-puncture headache, an epidural blood patch using 3-5 ml of autologous blood provided complete relief for all patients within an hour, with only one case of recurrence (5%).

The treatment showed no side effects and aligns with existing literature that reports high success rates (73-98%) for this method, suggesting it is a safe and effective option for managing severe headaches following lumbar puncture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Epidural injection of autologous blood for postlumbar-puncture headache]. Stojsavljević, N., Drulović, J.[2009]

Accidental insertion of a peridural catheter into the lumbar venous plexus can lead to complications, as demonstrated by an angiogram showing the vascular puncture.

The study discusses the risks associated with vascular puncture during procedures and suggests methods to prevent intravascular injection of local anesthetics, highlighting the importance of careful technique in epidural catheter placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Problems of accidental blood vessel puncture in peridural anesthesia]. Beck, H., Doehn, M., Brassow, F.[2013]

The technique of injecting the lateral sacral and ascending lumbar veins, combined with abdominal compression, effectively opacifies the entire lumbar epidural venous system, enhancing visualization.

This method is particularly valuable for diagnosing disc herniations, as it provides clearer anatomical details that can aid in accurate assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumbar phlebography by catheterization of the lateral sacral and ascending lumbar veins with abdominal compression. Theron, J., Houtteville, JP., Ammerich, H., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Lumbar Artery Injury during Transforaminal Percutaneous Endoscopic Lumbar Discectomy: Successful Treatment by Emergent Transcatheter Arterial Embolization. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of epidural blood patches for spontaneous low-pressure headaches: a case series. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Epidural Contrast Volume on Post-Myelogram Lumbar CT Predicts the Rate of Subsequent Blood Patch Treatment. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Multiple lumbar punctures aiming to relieve headache results in iatrogenic spinal hematoma: a case report. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[Spinal catheter-associated cerebrospinal fluid leak]. [2018]

6. Turkey pubmed.ncbi.nlm.nih.gov

Lumbar Epidural Varicose Vein: Early Neurological Improvement and Late Radiological Full Recovery with Surgery; The Importance of Magnetic Resonance Imaging in Follow-Up. [2018]

7. Serbia pubmed.ncbi.nlm.nih.gov

[Epidural injection of autologous blood for postlumbar-puncture headache]. [2009]

8. Germany pubmed.ncbi.nlm.nih.gov

[Problems of accidental blood vessel puncture in peridural anesthesia]. [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

Lumbar phlebography by catheterization of the lateral sacral and ascending lumbar veins with abdominal compression. [2019]