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Eye ultrasound may reveal hidden brain pressure disorder

NCT ID NCT07085260

Knowledge-focused Sponsor: Yonsei University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study looks at whether measuring the optic nerve sheath diameter—the lining around the nerve that connects the eye to the brain—using ultrasound can help doctors know if a treatment for spontaneous intracranial hypotension (a condition where low spinal fluid causes severe headaches) is effective. Researchers will measure this diameter before, right after, and two weeks after an epidural blood patch procedure in 23 adults. They will also track headache severity and quality of life to see if changes in the nerve sheath match symptom improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
epidural blood patch
What this could lead to
If successful, this could establish a simple ultrasound measurement as a way to track whether treatment is working in patients with spontaneous intracranial hypotension.
What could go wrong
This is a small observational study with only 23 participants, so results may not apply to all patients. The measurement technique may not prove reliable enough for routine use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

23 people

The number who actually took part.

Started

Sep 2025

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

intracranial hypotension spontaneous intracranial hypotension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spontaneous intracranial hypotension

Contacts and locations

Locations

  • Severance Hospital

    Seoul, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.