Lumbar Vein Embolization for Chronic Headaches
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Must be taking: CSF pressure/volume lowering
Disqualifiers: Disc edema, Hematuria, Proteinuria, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345How 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.
36789Eligibility 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.
+8 more
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.
+1 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Coil embolization of lumbar veinExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic FloridaJacksonville, FL
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Lumbar Artery Injury during Transforaminal Percutaneous Endoscopic Lumbar Discectomy: Successful Treatment by Emergent Transcatheter Arterial Embolization. [2018]Injury to the lumbar artery during percutaneous endoscopic lumbar discectomy (PELD) is a very severe complication and only rarely reported. We present a 64-year-old patient with an injury to the right third lumbar artery during PELD which was successfully treated with intraoperative angiography and coil embolization. To our knowledge, this is the first report of the use of intraoperative angiography and coil embolization to treat a lumbar artery that had been lacerated during PELD.
Efficacy of epidural blood patches for spontaneous low-pressure headaches: a case series. [2018]Patients with a spontaneous cerebrospinal fluid leak, normally at a spinal level, typically present with low-pressure headache. In refractory cases, an epidural blood patch may be attempted. We aimed to assess the efficacy of lumbar epidural blood patching in spontaneous, low-pressure headaches. Methods We retrospectively analysed notes of patients who had an epidural blood patch performed for spontaneous low-pressure headaches in a single centre. Information regarding demographics, radiology and clinic follow-up was extracted from an electronic patient record system. Questionnaires regarding outcome were sent to patients a minimum of 6 months post-procedure. All patients received an epidural blood patch in the lumbar region irrespective of the site of cerebrospinal fluid leak. Results Sixteen patients who underwent lumbar epidural blood patching were analysed (11 female; mean age 43 years). The site of cerebrospinal fluid leak was evident in only 3/16 patients. Thirteen patients attended clinic follow-up; three reported complete headache resolution, four reported improvement in intensity or frequency and six described no change. Five of eight questionnaire respondents reported reduction in pain, and in these responders, mean headache severity improved from 9/10 to 3/10. Five of eight patients returning follow-up questionnaires reported sustained improvement in headache symptoms. Conclusion Epidural blood patch procedures can provide sustained improvement in headache symptoms in selected patients with spontaneous intracranial hypotension, but an untargeted approach has a lower success rate than reported in other case series.
Epidural Contrast Volume on Post-Myelogram Lumbar CT Predicts the Rate of Subsequent Blood Patch Treatment. [2021]Headaches due to cerebrospinal fluid (CSF) leakage are a well-known complication of dural puncture. The purpose of this study was to determine whether the presence and volume of epidural contrast on postmyelogram CTs of the lumbar spine were associated with post-dural puncture headaches (PDPHs) requiring epidural blood patch (EBP) treatment.
Multiple lumbar punctures aiming to relieve headache results in iatrogenic spinal hematoma: a case report. [2022]Multiple lumbar punctures have historically been a strategy to relieve headaches associated with idiopathic intracranial hypertension despite limited clinical evidence of long-term efficacy. Lumbar puncture is typically a straightforward procedure with minimal complications reported, however, serious complications can occur. Lumbar-puncture-related spinal hematomas are rare but can lead to irreversible paralysis.
[Spinal catheter-associated cerebrospinal fluid leak]. [2018]Cerebrospinal fluid leak, with its typical postdural puncture headache, occurs in 8-25 % of patients after insertion of a spinal catheter for treatment with an intrathecal pain pump. Symptoms are usually self-limiting; only rarely is an epidural blood patch used. In this case of a 49-year-old woman, we assumed a postdural puncture headache after replacement of the spinal catheter. Because of the persistence of symptoms and serous wound secretion around the paravertebral incision, we decided to test the catheter under radiological control with a contrast agent. Leakage could be seen within the spinal catheter, which was responsible for the symptoms. Because of an ongoing infection accompanied by meningitis the whole system had to be removed.
Lumbar Epidural Varicose Vein: Early Neurological Improvement and Late Radiological Full Recovery with Surgery; The Importance of Magnetic Resonance Imaging in Follow-Up. [2018]A lumbar epidural varicose vein is a rare clinical condition that can lead to neurological deficits. 3 types of lumbar epidural varicose veins were described according to the magnetic resonance imaging (MRI) findings: Type 1 is a thrombosed dilated epidural vein, type 2 is a non-thrombosed dilated epidural vein and type 3 is a sub-membraneous epidural hematoma. Enlarged epidural venous plexuses must be decompressed if they have lead to a neurological deficit. Surgical treatment is by excision or disrupting the cyst's integrity. We present a case of lumbar epidural varicose vein that was surgically treated twice and showed no radiological change despite the disruption of integrity with a partial excision. The lesion spontaneously and completely disappeared in the late period. We emphasize the importance of MRI in follow-up.
[Epidural injection of autologous blood for postlumbar-puncture headache]. [2009]The most frequent complication of lumbar puncture is headache. It is due to lowered intracranial tension produced by a continued leakage of cerebrospinal fluid (CSF) through the dural puncture site. Epidural injection of autologous blood has been frequently reported as highly effective in the treatment of lumbar-puncture-induced headache, with success rates of 73 to 98%. To our knowledge, in Yugoslavia there has been, so far, no report, concerning the use of this techique. The aim of this study is to evaluate the treatment of postlumbar-puncture headache by epidural blood patch in our 20 patients. Here we also describe one patient with severe headache induced by lumbar puncture, in whom we documented the CSF pressure less than atmospheric. Criteria for selection into the study included: subjective evaluation of the extent of headache and accompanying symptoms, duration of symptoms more than 48 hours, and failure of headache relief with conservative measures. We injected 3-5 ml of aseptically obtained autologous blood at the site of suspected dural puncture. When evaluated an hour after treatment, all patients experienced complete relief. In only one (5%) of 20 treated patients, headache reccurred after initial relief. We have not observed any side-effects in our patients. Our results are in harmony with the published high efficiencies of autologous epidural blood patch in the treatment of postlumbar-puncture headache. We recommend the injection of 5 ml of autologous blood in the epidural space in all patients with severe lumbar-puncture-induced headache, resistant to conservative therapy, lasting more than 24-48 hours.
[Problems of accidental blood vessel puncture in peridural anesthesia]. [2013]An angiogram of the lumbar venous plexus was obtained following accidental insertion of a peridural catheter into the plexus. The problem of vascular puncture is discussed and the possible methods of prevention of intravascular injection of local anaesthetic are outlined.
Lumbar phlebography by catheterization of the lateral sacral and ascending lumbar veins with abdominal compression. [2019]The lumbar epidural veins are opacified by injection of the lateral sacral and ascending lumbar veins with abdominal compression. This technique provides a good opacification of the entire lumbar epidural venous system. Some anatomical points are discussed and clarified. The interest of the technique in the diagnosis of discal herniations is emphasized.