"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 Type
OBSERVATIONAL
Enrollment
23
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks post-EBP
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.
Time frame: Baseline and 2 weeks post-EBP
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