A Clinical Registry of Spontaneous Intracranial Hypotension

Recruiting

• Conditions: Spontaneous Intracranial Hypotension

• Registration Number: NCT05922514
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2023-06-18
• Study First Submitted: 2023-06-19
• Study First Submitted QC: 2023-06-19
• Study First Posted: 2023-06-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Read More

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).

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Bern SIH MRI Score	Baseline, 3 months	The Bern SIH MRI score is a validated 9-point score assessing the severity of imaging finding suggestive of SIH. Calculated by adding the individual components for a score range of 0-9. Classified as low, intermediate, or high probability of having a CSF leak based on total Bern SIH score of 2 points or fewer (low), 3-4 points (intermediate), or 5 points or more (high).
Change in Headache Impact Test (HIT-6)	Baseline, 3 months	HIT-6 is a 6-item validated headache assessment tool designed to provide a global measure of headache impact in social functioning, role functioning, vitality, cognition, psychological distress, and severity of headache. Total score ranges 36-78: 36-49: little or no impact; 50-55 some impact; 56-59 substantial impact; \>60 severe impact.

Secondary Outcome Measures

Name	Time	Method
Change in Pain Numerical Rating Scale (NRS)	Baseline, 3 months	Subjects are asked to rate pain intensity in the past 7 days using a scale of 0 is no pain and 10 is the worst imaginable pain.
Change in Migraine Disability Assessment (MIDAS)	Baseline, 3 months	MIDAS 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21+ severe disability.

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States