Enrolling by invitation
Observational
Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study
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
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)
| Facility | City | Region | Status |
| Danish Headache Center |
Glostrup Municipality |
Copenhagen |
|
More Danish Headache Center trials in Denmark