Intracranial Hypotension, Post-Lumbar Puncture Headache, Spontaneous Intracranial Hypotension
Conditions
Keywords
Spontaneous Intracranial Hypotension, SIH, Post-Lumbar Puncture Headache, PLPH, Danish Headache Center, Post-Dural Puncture Headache, PDPH
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.
Interventions
None listed
Sponsors
Danish Headache Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the change in clinical biomarkers measured before and after successful treatment. | From enrollment to 1 year post-treatment. |
Countries
Denmark
Outcome results
None listed