The Freiburg Registry on SpontanEous IntercrAnial Hypotension (SIH) & Post-duraL Puncture Headache (PDPH)
Recruiting now
Conditions studied: CerebroSpinal Fluid (CSF) Leak
In brief
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.
Key facts
- Study ID
- NCT06711731
- Run by
- University Hospital Freiburg
- People needed
- 2000
- Starts
- 2024-11-04
- Expected to finish
- 2036-12-04
- Last updated by the study team
- 2024-12-02
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with suspected spinal CSF leak based on one of the following
- History of new orthostatic symptomes with or without prior spinal procedure
- Imaging suggestive for spinal CSF leak
- Informed consent
You may not qualify if…
- a) Symptoms beeing conclusively explained by another known diagnosis
Where it is running
- Medical Center - University of Freiburg, Germany — Freiburg im Breisgau, Germany (enrolling)
Full record on ClinicalTrials.gov
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