A Clinical Registry of Spontaneous Intracranial Hypotension

Study Overview
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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.

Official Title
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Spontaneous Intracranial Hypotension Registry

Conditions
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Spontaneous Intracranial Hypotension

Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 Baseline and 3 month Questionnaires<br>170 participants with BERN imaging score with completion of baseline and 3 month 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. | |
| Group 2 Baseline, 7 days and 3 month Questionnaires<br>30 participants with BERN imaging score with completion of baseline and 3 month 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |