NCT06805591

Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study

Clinical and Imaging Characteristics in Patients Suspected of Dural Leakage Before and After Treatment

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Danish Headache Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The goal of this observational study is to learn about the effects of a low-pressure environment on the brain in patients with intracranial hypotension and to potentially improve diagnostics and treatment of this condition. The primary objective will be: To investigate the change in clinical biomarkers measured before and after successful treatment. The secondary objectives will be: To investigate if clinical biomarkers can predict the outcome of treatment. Participants undergoing standard treatment for intracranial hypotension will undergo additional examinations and surveys and will be followed up for a year for the study.

Conditions

• Spontaneous Intracranial Hypotension
• Intracranial Hypotension
• Post-Lumbar Puncture Headache

Timeline

• Start date: 2024-12-10
• Primary completion: 2029-09-30
• Completion: 2029-09-30
• First posted: 2025-02-03
• Last updated: 2025-02-06

Locations

1 site across 1 country: Denmark