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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date August 2023
Source Mayo Clinic
Contact Theresa Nielson
Phone 507-422-0743
Email Nielson.Theresa@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Suspended NCT02603549 - Pituitary Function and Spontaneous Intracranial Hypotension
Completed NCT02261792 - Spontaneous Intracranial Hypotension Treatment "SIHT" N/A
Not yet recruiting NCT06374524 - Greater Occipital Nerve Block for Spontaneous Intracranial Hypotension

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