Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study

NCT ID: NCT06805591

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-10
• Study Completion Date: 2029-09-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with suspected Intracranial Hypotension

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.

No interventions assigned to this group

Control Group

Group consisting of healthy control participants.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danish Headache Center

OTHER

Sponsor Role: lead

Responsible Party

Henrik Schytz

Associate Professor, Consultant Neurologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henrik W Schytz, MD, Ph.D. DMSc

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center

Locations

Danish Headache Center

Glostrup Municipality, Copenhagen, Denmark

Countries

Denmark

Other Identifiers

NNF24OC0087919

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-24055595

Identifier Type: -

Identifier Source: org_study_id