Clinical trial NCT06805591: Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study
Official title: Clinical and Imaging Characteristics in Patients Suspected of Dural Leakage Before and After Treatment
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Spontaneous Intracranial Hypotension
Intracranial Hypotension
Post-Lumbar Puncture Headache
Keywords: Spontaneous Intracranial Hypotension
SIH
Post-Lumbar Puncture Headache
PLPH
Danish Headache Center
Post-Dural Puncture Headache
PDPH
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at the Danish Headache Center with suspected intracranial hypotension

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.


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.

Primary outcomes:
measure: To investigate the change in clinical biomarkers measured before and after successful treatment.
timeFrame: From enrollment to 1 year post-treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
state: Copenhagen
Study officials:
affiliation: Danish Headache Center
name: Henrik W Schytz, MD, Ph.D. DMSc
role: PRINCIPAL_INVESTIGATOR
References: