A Clinical Registry of Spontaneous Intracranial Hypotension
ConditionSpontaneous Intracranial Hypotension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula
Procedure/SurgeryTransvenous 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Group 1 Baseline, 3 months, 1 year, 1.5 years, and 2 years Questionnaires1 intervention
Group B: Group 2 Baseline, 7 days and 3 month, 1 year, 1.5 years, and 2 years Questionnaires1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 3 months, 1 year, 1.5 years, 2 years2
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).
Time frame
Baseline, 3 months, 1 year, 1.5 years, 2 yearsSecondary outcomes
1
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.
Time frame
Baseline, 3 months, 1 year, 1.5 years, 2 years2
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.
Time frame
Baseline, 3 months, 1 year, 1.5 years, 2 yearsSponsors and contacts
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Source ClinicalTrials.gov