A Clinical Registry of Spontaneous Intracranial Hypotension

Overview

About this study

The purpose of this study is to conduct a prospective clinical registry of up to 200 patients with Spontaneous Intracranial Hypotension (SIH) undergoing digital subtraction myelography (DSM) or CT myelography (CTM confirmed) CSF-venous fistulas treated with transvenous embolization. Surveys regarding pain will be collected at baseline before treatment, and at 90-days. Validation of SIHSSS survey for last 40 participants at baseline, days 4-7, and 90-days.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.
Adult patients ≥ 18 years old.

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.

Eligibility last updated 3/24/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Waleed Brinjikji, M.D.	Closed-enrolling by invitation What is this? (?) "Close" Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.	Contact information: Theresa Nielson C.C.R.C. (507) 422-0743 Nielson.Theresa@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Waleed Brinjikji, M.D.

Closed-enrolling by invitation

Contact information:

Theresa Nielson C.C.R.C.

(507) 422-0743

Nielson.Theresa@mayo.edu

More information

Publications

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