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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Baseline, 3 months, 1 year, 1.5 years, and 2 years Questionnaires | 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. |
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| Group 2 Baseline, 7 days and 3 month, 1 year, 1.5 years, and 2 years Questionnaires | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula | Procedure | Transvenous embolization of a cerebrospinal fluid-venous fistula performed via percutaneous venous access under fluoroscopic guidance. The procedure involves catheterization of the paraspinal or epidural venous system draining the fistula and delivery of an embolic agent to occlude the pathological venous outflow and eliminate CSF egress. The goal is to achieve durable fistula occlusion and resolution of spontaneous intracranial hypotension symptoms. |
| 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, 1 year, 1.5 years, 2 years |
| 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, 1 year, 1.5 years, 2 years |
| 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, 1 year, 1.5 years, 2 years |
| Change in Migraine Disability Assessment (MIDAS) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients being seen at Mayo Clinic in Rochester, Minnesota, for spontaneous intracranial hypotension (SIH) treatment evaluation by a neurologist with expertise in SIH. Patients would then be scheduled to meet with vascular radiology interventionalist for treatment (discussion and treatment(s) planning/scheduling purposes per standard of care. Patients would then speak with the study's coordinator to see if they would be interested to participant with and enroll in this study prior to SIH treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Theresa Nielson | Contact | 507-422-0743 | Nielson.Theresa@mayo.edu | |
| Gerard El Hajj, M.D. | Contact | 507-255-2860 | ElHajj.Gerard@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Waleed Brinjikji, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D019585 | Intracranial Hypotension |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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, 1 year, 1.5 years, 2 years |