A Clinical Registry of Spontaneous Intracranial Hypotension

Mayo Clinic

Status: Enrolling

Conditions: Spontaneous Intracranial Hypotension

Treatments: Procedure: Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula

Study type: Observational

Funder types: Other

Identifiers

NCT05922514

21-006331

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

200 participants in 2 patient groups

Group 1 Baseline, 3 months, 1 year, 1.5 years, and 2 years Questionnaires

Description:

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.

Treatment:

Procedure: Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula

Group 2 Baseline, 7 days and 3 month, 1 year, 1.5 years, and 2 years Questionnaires

Description:

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.

Treatment:

Procedure: Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula