A Clinical Registry of Spontaneous Intracranial Hypotension

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05922514
Status
Recruiting
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Conditions

  • Spontaneous Intracranial Hypotension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula — PROCEDURE
    Transvenous embolization of a cerebrospinal fluid-venous fistula performed via percutaneous venous access under fluoroscopic guidance. The procedure involves catheterization of the paraspinal or epidural venous system draining the fistula and delivery of an embolic agent to occlude the pathological venous outflow and eliminate CSF egress. The goal is to achieve durable fistula occlusion and resolution of spontaneous intracranial hypotension symptoms.

Study Details

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.

Key Dates

Start date
Jun 18, 2023
Status verified
Nov 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Group 1 Baseline, 3 months, 1 year, 1.5 years, and 2 years Questionnaires
    170 participants with BERN imaging score with completion of baseline, 3 months, 1 year, 1.5 years, and 2 years questionnaires being : headache impact test (HIT-6), migraine disability assessment test (MIDAS), pain numerical rating scale (NRS), and spontaneous intracranial hypotension symptom severity scale (SIHSS). Each participant will keep a daily headache diary for 90 days.
  • Arm: Group 2 Baseline, 7 days and 3 month, 1 year, 1.5 years, and 2 years Questionnaires
    30 participants with BERN imaging score with completion of baseline, 7 days, 3 months, 1 year, 1.5 years, and 2 years questionnaires being : headache impact test (HIT-6), migraine disability assessment test (MIDAS), pain numerical rating scale (NRS), and spontaneous intracranial hypotension symptom severity scale (SIHSS). Each participant will keep a daily headache diary for 90 days.

Primary Outcome Measure

Change in Headache Impact Test (HIT-6) [ Time Frame: Baseline, 3 months, 1 year, 1.5 years, 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic MinnesotaRochesterMinnesota55905
Theresa A Nielson
[email protected]
507 422 0743

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By research site
Mayo Clinic Minnesota· Rochester, MN

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