Clinical Trial

Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study

Study acronym: PATCHES
Enrolling by Invitation
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-28.
Trial Details
NCT Number NCT06805591
Lead Sponsor Danish Headache Center
Conditions Spontaneous Intracranial Hypotension, Intracranial Hypotension, Post-Lumbar Puncture Headache
Enrollment 400 participants
Start Date 2024-12-10
Primary Completion 2029-09-30 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-06