A Clinical Registry of Spontaneous Intracranial Hypotension

Spontaneous Intracranial Hypotension Clinical Trial

Official title:

Spontaneous Intracranial Hypotension Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05922514
• Other study ID #: 21-006331
• Status: Recruiting
• Start date: June 18, 2023
• Est. completion date: July 2026

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: Theresa Nielson
• Phone: 507-422-0743
• Email: Nielson.Theresa[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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).

Related Conditions & MeSH terms

• Hypotension
• Intracranial Hypotension
• Spontaneous Intracranial Hypotension

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Headache Impact Test (HIT-6)	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.	Baseline, 3 months
Primary	Change in Bern SIH MRI Score	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).	Baseline, 3 months
Secondary	Change in Pain Numerical Rating Scale (NRS)	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.	Baseline, 3 months
Secondary	Change in Migraine Disability Assessment (MIDAS)	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.	Baseline, 3 months

External Links

•   Mayo Clinic Clinical Trials