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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for chronic headaches using a procedure called coil embolization of the lumbar vein. Researchers aim to determine if this method, which blocks certain veins, can safely help individuals who have not found relief from other headache treatments. It targets those with daily pressure-like headaches that worsen when lying down and exhibit specific blood flow patterns on an MRI. For individuals whose traditional headache medicines have failed, and who experience these symptoms, this trial might be suitable. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for chronic headaches.

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 prior data suggests that this procedure is safe for treating chronic headaches?

Research has shown that blocking the lumbar vein might effectively treat chronic headaches caused by Nutcracker physiology. Studies have found that this procedure significantly reduces head pain in individuals with this condition.

Regarding safety, evidence suggests that the procedure is generally well-tolerated, with no major side effects reported in those who underwent the treatment. While more research is needed, it appears safe for participants so far.

However, individual experiences can vary. It is important to consult a healthcare provider about potential risks and benefits before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for chronic headaches focus on alleviating symptoms with medications like pain relievers or anti-inflammatory drugs. However, the coil embolization of the lumbar vein offers a unique approach by directly addressing the underlying vascular issue. This treatment targets the Nutcracker physiology and retrograde lumbar vein flow, which are believed to contribute to high-pressure headaches. Researchers are excited because this method has the potential to offer relief by correcting the venous congestion, potentially providing a more permanent solution rather than just managing symptoms.

What evidence suggests that coil embolization of the lumbar vein might be an effective treatment for chronic headaches?

Research has shown that lumbar vein embolization, a procedure participants in this trial will undergo, may help treat chronic headaches in some patients. In one study, patients with nutcracker physiology—a condition where a vein near the kidney is compressed, causing increased pressure and pain—experienced significant headache relief after this procedure. This suggests that blocking the lumbar vein can reduce headache symptoms for those with specific blood flow issues. The procedure targets the lumbar vein to relieve pressure in the veins around the spine, potentially easing headaches. While the results are promising, further research is needed to confirm these findings in larger groups. ^{1 2 3 6 7}

Who Is on the Research Team?

Zlatko Devcic, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10666676/

case series with lumbar vein embolization as a therapeutic ... Our results suggest that embolization of L2LV in a specific patient population with nutcracker physiology may substantially improve head pain issues.

2. ctv.veeva.com ctv.veeva.com/study/lumbar-vein-embolization-for-chronic-headaches-with-nutcracker-physiology

Lumbar Vein Embolization for Chronic Headaches with ... The purpose of this research is to gather information on the safety and feasibility of coiling the lumbar vein for the treatment of chronic ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20555122

Effectiveness of Coiling the Lumbar Vein for the Treatment ... The purpose of this study is to determine the effectiveness of coiling the lumbar vein for the treatment of chronic headache in the setting of Nutcracker ...

4. withpower.com withpower.com/trial/phase-headache-disorders-11-2023-7a71e

Lumbar Vein Embolization for Chronic Headaches This trial is for individuals with chronic headaches that feel like pressure, worsen when lying back, and have been resistant to various treatments.

5. researchgate.net researchgate.net/publication/363566989_Daily_persistent_headache_with_nutcracker_physiology_and_spinal_epidural_venous_congestion_Treatment_with_lumbar_vein_embolization

Treatment with lumbar vein embolization We now present a case series of four patients with long-term follow-up utilizing lumbar vein coil embolization as a new therapeutic approach.

6. trialstoday.org trialstoday.org/trial/NCT06077747

Lumbar Vein Embolization for Chronic Headaches with ... The purpose of this research is to gather information on the safety and feasibility of coiling the lumbar vein for the treatment of chronic ...

7. karger.com karger.com/crn/article/16/1/71/895417/A-Possible-Newly-Defined-and-Treatable-Secondary

A Possible Newly Defined and Treatable Secondary Cause ... After treatment with lumbar vein coil embolization, which alleviated the spinal cord venous congestion, her headaches alleviated. Case Report: A ...