RECRUITING

A Clinical Registry of Spontaneous Intracranial Hypotension

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 determine the efficacy of paraspinal vein embolization for treatment of digital subtraction myelography (DSM) or CT myelography (CTM) confirmed cerebrospinal fluid (CSF)-venous fistulas so that researchers can inform the development and design of future clinical trials of this technique.

Official Title

Spontaneous Intracranial Hypotension Registry

Quick Facts

Study Start:2023-06-18
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05922514

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. * Study subjects will be patients who meet the International Classification of Headache - Disorders 3rd Edition (ICHD-3) criteria for a diagnosis of SIH or the Schievink criteria with imaging confirmed CSF-venous fistulas on DSM or CTM.
  2. * Availability of a clinically prescribed contrast enhanced MRI positive for SIH.
  3. * Negative urine or serum pregnancy test at time of study consent and three-months.
  1. * Patients who have a contraindication or inability to undergo the procedure (i.e., severe contrast allergy).
  2. * Inability to provide informed consent.
  3. * Expected inability to complete the follow-up assessment.
  4. * Current pregnancy or breast-feeding during study enrollment (from consent to study conclusion approximately 90-days).

Contacts and Locations

Study Contact

Theresa Nielson
CONTACT
507-422-0743
Nielson.Theresa@mayo.edu

Principal Investigator

Waleed Brinjikji, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic Minnesota
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Waleed Brinjikji, 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 Date2023-06-18
Study Completion Date2026-07

Study Record Updates

Study Start Date2023-06-18
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Spontaneous Intracranial Hypotension