Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study

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

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.

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.