Spontaneous Intracranial HypotensionNCT07085260
ONSD Changes and Treatment Response After Epidural Blood Patch in Spontaneous Intracranial Hypotension
An observational study of Spontaneous Intracranial Hypotension, run by Yonsei University at 1 site in South Korea.
Trial summary
"This is a prospective observational study investigating changes in optic nerve sheath diameter (ONSD) and its association with clinical improvement following epidural blood patch (EBP) in patients with spontaneous intracranial hypotension (SIH). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Spontaneous Intracranial Hypotension
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Sep 2025to 6 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will include adults aged ≥19 years who are scheduled to receive their first epidural blood patch (EBP) at Severance Hospital for clinically diagnosed spontaneous intracranial hypotension (SIH), based on the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria by the International Headache Society. Only patients who voluntarily provide written informed consent after receiving sufficient explanation about the study's objectives and procedures will be enrolled. All participants must be legally capable of providing consent.
Who may be able to join
- dults aged 19 years or older diagnosed with spontaneous intracranial hypotension (SIH) according to the 3rd edition of the International Classification of Headache Disorders (ICHD-3), and scheduled to undergo their first epidural blood patch (EBP) at our institution.
- Individuals who have received sufficient explanation of the study purpose and procedures, and voluntarily provided written informed consent with full legal capacity.
Who cannot join
- Patients younger than 19 years. Patients with secondary headache clearly attributable to other causes such as trauma, medications, or infections.
- Individuals who are unable or unwilling to voluntarily provide informed consent for study participation.
- Patients with cognitive impairment, psychiatric disorders, or language difficulties that interfere with completing questionnaires or clinical assessments.
- Patients with medical contraindications to EBP, such as active infection or bleeding tendency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time-series Changes in Optic Nerve Sheath Diameter and Its Association With Treatment Response After Epidural Blood Patch in Patients With Spontaneous Intracranial Hypotension
"This is a prospective observational study investigating changes in optic nerve sheath diameter (ONSD) and its association with clinical improvement following epidural blood patch (EBP) in patients with spontaneous intracranial hypotension (SIH). SIH is a secondary headache disorder caused by cerebrospinal fluid (CSF) leakage or low CSF pressure and is often underdiagnosed due to its diverse and nonspecific presentation.
ONSD, measured via ocular ultrasonography, has emerged as a non-invasive surrogate marker for intracranial pressure (ICP), with its diameter decreasing in states of intracranial hypotension. Prior studies suggest that posture-related ONSD differences (e.g., between supine and upright positions) may be more sensitive in SIH than static values alone, and that ONSD may increase following dural repair, correlating with symptom improvement. However, no studies to date have systematically examined the time-series evolution of ONSD around EBP in SIH patients.
Read more
In this study, adult patients diagnosed with SIH and scheduled for their first EBP at our hospital will be enrolled. ONSD will be measured using standardized ultrasound protocols at three timepoints: immediately before EBP (T0), immediately after EBP (T1), and at follow-up admission two weeks later (T2). Measurements will be taken in both supine and upright positions at each timepoint to calculate posture-related changes (ΔONSD = supine - upright).
Concurrently, clinical symptom assessments will be conducted using standardized instruments: Numeric Rating Scale (NRS) for headache intensity, HIT-6 for headache impact, PHQ-9 and GAD-7 for emotional distress, and EQ-5D-5L for quality of life. These will be administered at T0 and T2.
Primary outcomes include the change in ΔONSD over time. Secondary outcomes involve the correlation between ΔONSD and clinical improvement metrics (e.g., reduction in NRS or HIT-6 scores). Descriptive and inferential statistics will be performed, including repeated measures ANOVA or Friedman test for time-series data, and Pearson or Spearman correlation for association analysis.
All ONSD measurements and EBP procedures will be performed by the same experienced anesthesiologist following a standardized institutional protocol. This study aims to evaluate whether ONSD can serve as a quantitative imaging biomarker reflecting treatment responsiveness in SIH.
- Conditions
- Spontaneous Intracranial Hypotension
- Medical subject headings
- Intracranial Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Optic Nerve Sheath Diameter (ΔONSD) across three time points
Measurement of optic nerve sheath diameter (ONSD) in both supine and upright positions using standardized ocular ultrasonography at three time points. The primary variable is ΔONSD (supine - upright), and the primary outcome is the time-series change of ΔONSD after epidural blood patch (EBP) treatment in patients with spontaneous intracranial hypotension (SIH). Changes will be analyzed using repeated measures ANOVA or nonparametric equivalents depending on distribution.
Measured: Baseline (pre-EBP)
Change in Optic Nerve Sheath Diameter (ΔONSD) across three time points
Measurement of optic nerve sheath diameter (ONSD) in both supine and upright positions using standardized ocular ultrasonography at three time points. The primary variable is ΔONSD (supine - upright), and the primary outcome is the time-series change of ΔONSD after epidural blood patch (EBP) treatment in patients with spontaneous intracranial hypotension (SIH). Changes will be analyzed using repeated measures ANOVA or nonparametric equivalents depending on distribution.
Measured: immediate post-EBP (within 1 hour)
Change in Optic Nerve Sheath Diameter (ΔONSD) across three time points
Measurement of optic nerve sheath diameter (ONSD) in both supine and upright positions using standardized ocular ultrasonography at three time points. The primary variable is ΔONSD (supine - upright), and the primary outcome is the time-series change of ΔONSD after epidural blood patch (EBP) treatment in patients with spontaneous intracranial hypotension (SIH). Changes will be analyzed using repeated measures ANOVA or nonparametric equivalents depending on distribution.
Measured: 2 weeks post-EBP
Secondary outcomes (1)
Correlation between changes in ΔONSD and clinical symptom improvement
To evaluate the association between ΔONSD change and changes in clinical assessment scores, including Numeric Rating Scale (NRS), Headache Impact Test-6 (HIT-6), Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and EQ-5D-5L. Correlation analysis (Pearson or Spearman) will be performed based on data distribution.
Measured: Baseline and 2 weeks post-EBP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start22 Sep 2025
- Primary completion6 Apr 2026
- Study completion6 Apr 2026
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 Yonsei UniversityThe 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085260
- Sponsor's protocol ID
- 4-2025-0662
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-series Changes in Optic Nerve Sheath Diameter and Its Association With Treatment Response After Epidural Blood Patch in Patients With Spontaneous Intracranial Hypotension
- ClinicalTrials.gov ID
- NCT07085260
- Acronym / sponsor ID
- 4-2025-0662
- Conditions
- Spontaneous Intracranial Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 25 Jul 2025 (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.
"This is a prospective observational study investigating changes in optic nerve sheath diameter (ONSD) and its association with clinical improvement following epidural blood patch (EBP) in patients with spontaneous intracranial hypotension (SIH). SIH is a secondary headache disorder caused by cerebrospinal fluid (CSF) leakage or low CSF pressure and is often underdiagnosed due to its diverse and nonspecific presentation.
ONSD, measured via ocular ultrasonography, has emerged as a non-invasive surrogate marker for intracranial pressure (ICP), with its diameter decreasing in states of intracranial hypotension. Prior studies suggest that posture-related ONSD differences (e.g., between supine and upright positions) may be more sensitive in SIH than static values alone, and that ONSD may increase following dural repair, correlating with symptom improvement. However, no studies to date have systematically examined the time-series evolution of ONSD around EBP in SIH patients.
In this study, adult patients diagnosed with SIH and scheduled for their first EBP at our hospital will be enrolled. ONSD will be measured using standardized ultrasound protocols at three timepoints: immediately before EBP (T0), immediately after EBP (T1), and at follow-up admission two weeks later (T2). Measurements will be taken in both supine and upright positions at each timepoint to calculate posture-related changes (ΔONSD = supine - upright).
Concurrently, clinical symptom assessments will be conducted using standardized instruments: Numeric Rating Scale (NRS) for headache intensity, HIT-6 for headache impact, PHQ-9 and GAD-7 for emotional distress, and EQ-5D-5L for quality of life. These will be administered at T0 and T2.
Primary outcomes include the change in ΔONSD over time. Secondary outcomes involve the correlation between ΔONSD and clinical improvement metrics (e.g., reduction in NRS or HIT-6 scores). Descriptive and inferential statistics will be performed, including repeated measures ANOVA or Friedman test for time-series data, and Pearson or Spearman correlation for association analysis.
All ONSD measurements and EBP procedures will be performed by the same experienced anesthesiologist following a standardized institutional protocol. This study aims to evaluate whether ONSD can serve as a quantitative imaging biomarker reflecting treatment responsiveness in SIH.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will include adults aged ≥19 years who are scheduled to receive their first epidural blood patch (EBP) at Severance Hospital for clinically diagnosed spontaneous intracranial hypotension (SIH), based on the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria by the International Headache Society. Only patients who voluntarily provide written informed consent after receiving sufficient explanation about the study's objectives and procedures will be enrolled. All participants must be legally capable of providing consent.
Key inclusion criteria (2 listed)
- dults aged 19 years or older diagnosed with spontaneous intracranial hypotension (SIH) according to the 3rd edition of the International Classification of Headache Disorders (ICHD-3), and scheduled to undergo their first epidural blood patch (EBP) at our institution.
- Individuals who have received sufficient explanation of the study purpose and procedures, and voluntarily provided written informed consent with full legal capacity.
Key exclusion criteria (4 listed)
- Patients younger than 19 years. Patients with secondary headache clearly attributable to other causes such as trauma, medications, or infections.
- Individuals who are unable or unwilling to voluntarily provide informed consent for study participation.
- Patients with cognitive impairment, psychiatric disorders, or language difficulties that interfere with completing questionnaires or clinical assessments.
- Patients with medical contraindications to EBP, such as active infection or bleeding tendency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Optic Nerve Sheath Diameter (ΔONSD) across three time points
Time frame: Baseline (pre-EBP)
Measurement of optic nerve sheath diameter (ONSD) in both supine and upright positions using standardized ocular ultrasonography at three time points. The primary variable is ΔONSD (supine - upright), and the primary outcome is the time-series change of ΔONSD after epidural blood patch (EBP) treatment in patients with spontaneous intracranial hypotension (SIH). Changes will be analyzed using repeated measures ANOVA or nonparametric equivalents depending on distribution.
Change in Optic Nerve Sheath Diameter (ΔONSD) across three time points
Time frame: immediate post-EBP (within 1 hour)
Measurement of optic nerve sheath diameter (ONSD) in both supine and upright positions using standardized ocular ultrasonography at three time points. The primary variable is ΔONSD (supine - upright), and the primary outcome is the time-series change of ΔONSD after epidural blood patch (EBP) treatment in patients with spontaneous intracranial hypotension (SIH). Changes will be analyzed using repeated measures ANOVA or nonparametric equivalents depending on distribution.
Change in Optic Nerve Sheath Diameter (ΔONSD) across three time points
Time frame: 2 weeks post-EBP
Measurement of optic nerve sheath diameter (ONSD) in both supine and upright positions using standardized ocular ultrasonography at three time points. The primary variable is ΔONSD (supine - upright), and the primary outcome is the time-series change of ΔONSD after epidural blood patch (EBP) treatment in patients with spontaneous intracranial hypotension (SIH). Changes will be analyzed using repeated measures ANOVA or nonparametric equivalents depending on distribution.
1 secondary outcome
Correlation between changes in ΔONSD and clinical symptom improvement
Time frame: Baseline and 2 weeks post-EBP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Yonsei University at 1 site in South Korea.
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 2 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: finished, as of the sponsor's last update on 2 Jul 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Optic Nerve Sheath Diameter (ΔONSD) across three time points (time frame: Baseline (pre-EBP)). The study lists 3 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 2 Jul 2026.