NCT06711731 The Freiburg Registry on SpontanEous IntercrAnial Hypotension (SIH) & Post-duraL Puncture Headache (PDPH)
| NCT ID | NCT06711731 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Freiburg |
| Condition | CerebroSpinal Fluid (CSF) Leak |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2024-11-04 |
| Primary Completion | 2034-12-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2024-11-04 with a primary completion date of 2034-12-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. 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 2. Informed consent Exclusion Criteria: a) Symptoms beeing conclusively explained by another known diagnosis
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06711731 clinical trial?
This trial is open to participants of all sexes, studying CerebroSpinal Fluid (CSF) Leak. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06711731 currently recruiting?
Yes, NCT06711731 is actively recruiting participants. Contact the research team at katharina.wolf@uniklinik-freiburg.de for enrollment information.
Where is the NCT06711731 trial being conducted?
This trial is being conducted at Freiburg im Breisgau, Germany.
Who is sponsoring the NCT06711731 clinical trial?
NCT06711731 is sponsored by University Hospital Freiburg. The trial plans to enroll 2,000 participants.