Lumbar Vein Embolization for Chronic Headaches
What You Need to Know Before You Apply
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.
How does the treatment Lumbar Vein Embolization for Chronic Headaches differ from other treatments for this condition?
What data supports the effectiveness of the treatment Lumbar Vein Embolization for Chronic Headaches?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Evaluation
Participants undergo detailed headache history, physical examination, and various tests including MRI and venography to confirm eligibility
Treatment
Participants undergo lumbar vein embolization procedure
Follow-up
Participants are monitored for symptom evaluation and adverse events post-procedure
What Are the Treatments Tested in This Trial?
Interventions
- Coil Embolization of the Lumbar Vein
Coil Embolization of the Lumbar Vein is already approved in United States for the following indications:
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Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor