Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study (PATCHES)

Danish Headache Center

Status: Invitation-only

Conditions: Spontaneous Intracranial Hypotension; Post-Lumbar Puncture Headache; Intracranial Hypotension

Study type: Observational

Funder types: Other

Identifiers

NCT06805591

H-24055595

NNF24OC0087919 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

400 participants in 2 patient groups

Patients with suspected Intracranial Hypotension

Description:

Patients will be included in the cohort if suspected of intracranial hypotension. The group will therefore be subgrouped into patients with spontaneous intracranial Hypotension, post-lumbar puncture headache, and patients suspected but not demonstrated with intracranial hypotension.

Control Group

Description:

Group consisting of healthy control participants.