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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Migraine Disability Assessment

Change in headache pain

Secondary outcome measures

Adverse Events

Serious Adverse Events

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

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Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,767,079 Total Patients Enrolled

Zlatko Devcic, MDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies for participants in this research project?

"Clinicaltrials.gov data indicates that this medical research program, originally posted on December 1st 2023 and edited lastly in October 5th 2023, is not currently recruiting patients. However, 133 other trials are still presently taking partakers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology

Zlatko Devcic 2024. "Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06077747.

All > Chronic Daily Headache