RecruitingNCT06711731

The Freiburg Registry on SpontanEous IntercrAnial Hypotension (SIH) & Post-duraL Puncture Headache (PDPH)


Sponsor

University Hospital Freiburg

Enrollment

2,000 participants

Start Date

Nov 4, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Spinal CSF leaks are considered as rare disease. They cause a variety of symptoms, mainly culminating in a chronic headache syndrome. Crucially, yet often disregarded, the disease holds the potential for cure. The multitude of symptoms, and their inconsistency over time are just two of many challenges preventing timely diagnosis and treatment in many patients. Spinal CSF leaks can occur after intentional or accidental dural puncture (post-dural puncture headache - PDPH) or spontaneously (spontaneous intracranial hypotension - SIH). Awareness is steadily increasing with simultaneous increase of recognized patients. Yet, research and diagnostic is mainly provided by few specialized centers, as e.g. Freiburg. Thus, many observations point towards a large non-diagnosed and non-recognized number of patients, most likely being misdiagnosed and mistreated. Objective: The aim of the registry is to collect structured information on the frequency, cause, symptoms, diagnostic procedures, treatment options and long-term outcome. With the help of the registry, we would like to contribute to a better understanding and treatment of the diseases. Methods: Prospective, longitudinal registry on patients with suspected SIH or PDPH, including data on demographics, clinical presentation, diagnostic findings, treatment, at treatment outcome.


Eligibility

Plain Language Summary

Simplified for easier understanding

This registry is prospectively collecting detailed clinical, imaging, and treatment data on patients with spinal cerebrospinal fluid (CSF) leaks — either occurring spontaneously (spontaneous intracranial hypotension) or after a medical procedure involving the spine (post-dural puncture headache) — to better understand these underdiagnosed conditions that cause debilitating positional headaches and other neurological symptoms. CSF leaks are often misdiagnosed as migraine or psychiatric conditions for months or years, and this registry at Freiburg University Hospital aims to capture the full spectrum of presentations and outcomes to guide future research and treatment. Adults with suspected spinal CSF leaks based on new positional symptoms or supportive imaging who provide informed consent are eligible; those whose symptoms are fully explained by another confirmed diagnosis are excluded. Participation involves having existing clinical data collected over two years, with no additional hospital visits or tests beyond standard clinical care. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Medical Center - University of Freiburg, Germany

Freiburg im Breisgau, Germany

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NCT06711731


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