Spontaneous Intracranial Hypotension Registry
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Minnesota
Mayo Clinic Minnesota
RECRUITING
Rochester
Contact Information
Primary
Theresa Nielson
Nielson.Theresa@mayo.edu
507-422-0743
Backup
Gerard El Hajj, M.D.
ElHajj.Gerard@mayo.edu
507-255-2860
Time Frame
Start Date: 2023-06-18
Estimated Completion Date: 2026-07
Participants
Target number of participants: 200
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic