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A Clinical Registry of Spontaneous Intracranial Hypotension

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  • 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.
  • Availability of a clinically prescribed contrast enhanced MRI positive for SIH.
  • Negative urine or serum pregnancy test at time of study consent and three-months.

Exclusion Criteria:

  • Patients who have a contraindication or inability to undergo the procedure (i.e., severe contrast allergy).
  • Inability to provide informed consent.
  • Expected inability to complete the follow-up assessment.
  • Current pregnancy or breast-feeding during study enrollment (from consent to study conclusion approximately 90-days).

Study details

Spontaneous Intracranial Hypotension

NCT05922514

Mayo Clinic

25 January 2024

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