Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study

• Conditions: Spontaneous Intracranial Hypotension; Intracranial Hypotension; Post-Lumbar Puncture Headache

• Registration Number: NCT06805591
• Lead Sponsor: Danish Headache Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-10
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Status Verified: 2025-02
• Study First Posted: 2025-02-03
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-06
• Primary Completion: 2029-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the change in clinical biomarkers measured before and after successful treatment.	From enrollment to 1 year post-treatment.

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Copenhagen, Denmark