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Enrolling by invitation Observational

Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study

NCT06805591 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2024-12-10
Last updated
2025-02-06

Condition(s) studied

Spontaneous Intracranial HypotensionIntracranial HypotensionPost-Lumbar Puncture Headache

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria (patients): * Age 18-80. * Patients with a suspected intracranial hypotension diagnosis. * Participants must read and understand the Danish language or have an official interpreter present to be able to understand the work-up and sign the participation consent for the study. Inclusion Criteria (Control): * Age 18-80. * Healthy people who do not suffer from any form of primary headache except infrequent tension-type headache. * Participants must read and understand the Danish language or have an official interpreter present to be able to sign the participation consent for the study. Exclusion Criteria (patients): * Pregnant or breastfeeding females * Patients in whom the examination cannot be performed due to anatomical reasons such as severe head dysmorphia or severe ophthalmological diseases. * The patient has a disease, takes medication, or abuses alcohol or drugs that could, in the investigator´s opinion interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study. * The patient is, in the investigator´s opinion, unlikely to comply with the protocol or is unsuitable for any reason. Exclusion Criteria (Control): * Pregnant or breastfeeding females * Participants in whom the examination cannot be performed due to anatomical reasons such as severe head dysmorphia or severe ophthalmological diseases. * The participant has a disease, takes medication, or abuses alcohol or drugs that could, in the investigator´s opinion interfere with the interpretation of the study.

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Danish Headache Center Glostrup Municipality Copenhagen
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06805591 on ClinicalTrials.gov ↗ ← All trials in Denmark