Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Spontaneous Intracranial Hypotension, Intracranial Hypotension, Post-Lumbar Puncture Headache. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical and Imaging Characteristics in Patients Suspected of Dural Leakage Before and After Treatment
Overview
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.
Primary outcome measures
- To investigate the change in clinical biomarkers measured before and after successful treatment. [Time frame: From enrollment to 1 year post-treatment.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Danish Headache Center — Glostrup Municipality
Identifiers
NCT: NCT06805591 · H-24055595 · NNF24OC0087919