RECRUITING

Lumbar Vein Embolization for Chronic Headaches with Nutcracker Physiology

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Lumbar Vein Embolization for the Treatment of Chronic Headache in Patients with Nutcracker Physiology and Retrograde Lumbar Vein Flow with Epidural Venous Plexus Enhancement

Quick Facts

Study Start:2024-09-17
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06077747

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Daily headache from onset lasting \> 3 months.
  2. * Headache described as pressure sensation.
  3. * Headache worsened in the Trendelenburg position.
  4. * Exposed to CSF pressure/volume lowering medications.
  5. * Tried 2 of 4 unless contraindications: acetazolamide, methazolamide, indomethacin SR or spironolactone) or CSF volume removal via LP with positive or neutral response.
  6. * Failed at least 3 typical headache preventative medications from different classes-antidepressants, antiepileptic, blood pressure medications.
  7. * MRI demonstrates that Nutcracker physiology is present.
  8. * Decreased SMA angle, renal vein narrowing, decreased AMD.
  9. * Retrograde lumbar vein flow and early EVP enhancement.
  10. * Ability to understand study procedures and to comply with them for the entire length of the study.
  11. * Negative pregnancy test.
  1. * Evidence of disc edema.
  2. * Positive urinalysis for hematuria or proteinuria.
  3. * Abnormal CBC or CMP.
  4. * MRI, MRA head and neck and MR venogram with a possible secondary causes of headache including space occupying lesions, Chiari malformation, cerebral vein thrombosis, hydrocephalus, dissection, aneurysm etc.

Contacts and Locations

Study Contact

Julia Santos
CONTACT
904-953-3280
Santos.Julia@mayo.edu

Principal Investigator

Zlatko Devcic, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic Florida
Jacksonville, Florida, 32224
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Zlatko Devcic, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-17
Study Completion Date2027-09

Study Record Updates

Study Start Date2024-09-17
Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Headache
  • Nutcracker Phenomenon, Renal
  • Nutcracker Syndrome, Renal