Spontaneous Intracranial HypotensionNCT05922514
A Clinical Registry of Spontaneous Intracranial Hypotension
An observational study of Spontaneous Intracranial Hypotension, run by Mayo Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Intracranial Hypotension
- What is being tested?
- Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2023to Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Theresa A Nielson, 507 422 0743, nielson.theresa@mayo.edu
About this study
Official title: Spontaneous Intracranial Hypotension Registry
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.
- Conditions
- Spontaneous Intracranial Hypotension
- Being tested
- Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula
- Medical subject headings
- Intracranial Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvenous Embolization of Cerebrospinal Fluid-Venous FistulaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula | |
| 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. Receives: Procedure: Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline, 3 months, 1 year, 1.5 years, 2 years
Secondary outcomes (2)
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.
Measured: Baseline, 3 months, 1 year, 1.5 years, 2 years
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.
Measured: Baseline, 3 months, 1 year, 1.5 years, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start18 Jun 2023
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Intracranial HypotensionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Brinjikji, Mayo Clinic
- Investigators
- Waleed Brinjikji, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922514
- Sponsor's protocol ID
- 21-006331
- Status last verified
- Aug 2026
- First submitted
- 19 Jun 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaneous Intracranial Hypotension Registry
- ClinicalTrials.gov ID
- NCT05922514
- Acronym / sponsor ID
- 21-006331
- Conditions
- Spontaneous Intracranial Hypotension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Jun 2023 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Baseline, 3 months, 1 year, 1.5 years, and 2 years Questionnaires | – | Procedure: Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula170 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 | – | Procedure: Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula30 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvenous Embolization of Cerebrospinal Fluid-Venous FistulaTransvenous 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. | Procedure or surgery | Group 1 Baseline, 3 months, 1 year, 1.5 years, and 2 years Questionnaires, Group 2 Baseline, 7 days and 3 month, 1 year, 1.5 years, and 2 years Questionnaires |
Primary outcome
Change in Headache Impact Test (HIT-6)
Time frame: Baseline, 3 months, 1 year, 1.5 years, 2 years
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.
Change in Bern SIH MRI Score
Time frame: Baseline, 3 months, 1 year, 1.5 years, 2 years
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).
2 secondary outcomes
Change in Pain Numerical Rating Scale (NRS)
Time frame: Baseline, 3 months, 1 year, 1.5 years, 2 years
Change in Migraine Disability Assessment (MIDAS)
Time frame: Baseline, 3 months, 1 year, 1.5 years, 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Waleed Brinjikji, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Intracranial Hypotension, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerard El Hajj, M.D. (507-255-2860, ElHajj.Gerard@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Headache Impact Test (HIT-6) (time frame: Baseline, 3 months, 1 year, 1.5 years, 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.