Spontaneous Intracranial Hypotension Clinical Trial
Official title:
Spontaneous Intracranial Hypotension Registry
NCT number | NCT05922514 |
Other study ID # | 21-006331 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 18, 2023 |
Est. completion date | July 2026 |
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.
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). |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Minnesota | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
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 |
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