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Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATION

Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study

Clinical and Imaging Characteristics in Patients Suspected of Dural Leakage Before and After Treatment

NCT06805591•Danish Headache Center

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Danish Headache Center

Glostrup Municipality, Copenhagen, Denmark

Key Dates

Start Date

December 10, 2024

Primary Completion Date

September 30, 2029

Completion Date

September 30, 2029

Last Updated

February 6, 2025

Enrollment

400

ESTIMATED participants

Conditions

Spontaneous Intracranial HypotensionIntracranial HypotensionPost-Lumbar Puncture Headache

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Idiopathic Intracranial HypotensionVenous Sinus Stenosis

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NOT_YET_RECRUITINGNA

Blind Versus Targeted Epidural Patch With Autologous Platelet-rich Plasma for Spontaneous Intracranial Hypotension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study

Inclusion Criteria

Exclusion Criteria

Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)

Blind Versus Targeted Epidural Patch With Autologous Platelet-rich Plasma for Spontaneous Intracranial Hypotension

Spontaneous Intracranial Hypotension Treatment "SIHT"

Epidural Blood Patch on the Resolution of Postdural Puncture Headache (PDPH)

Postoperative Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Anesthesia for Cesarean Delivery

Headache After Diagnostic Lumbar Puncture