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Procedure

Lumbar Vein Embolization for Chronic Headaches

N/A

Waitlist Available

Led By Zlatko Devcic, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Exposed to CSF pressure/volume lowering medications

Failed at least 3 typical headache preventative medications from different classes-antidepressants, antiepileptic, blood pressure medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1,3,7,14, and 28 days after the procedure and then monthly for 17 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether a procedure to treat chronic headaches in specific patients is safe and effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated, potential side effects may include discomfort at the site of embolization, bleeding, infection risk from the procedure itself or reactions related to coil materials used during embolization.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have tried at least 3 different types of headache prevention medications without success.

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I have had daily headaches for more than 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1,3,7,14, and 28 days after the procedure and then monthly for 17 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1,3,7,14, and 28 days after the procedure and then monthly for 17 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1,3,7,14, and 28 days after the procedure and then monthly for 17 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Migraine Disability Assessment

Change in headache pain

Secondary study objectives

Adverse Events

Serious Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 3Eligibility criteria met