A Clinical Registry of Spontaneous Intracranial Hypotension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-18

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Spontaneous Intracranial Hypotension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula

Intervention Type 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.

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.

Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula

Intervention Type 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.

Interventions

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Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No