Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study (PATCHES)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Intracranial Hypotension; Spontaneous Intracranial Hypotension; Post-Lumbar Puncture Headache

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Glostrup, Copenhagen, Denmark, 2600
      • Danish Headache Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients at the Danish Headache Center with suspected intracranial hypotension

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
Control Group; Group consisting of healthy control participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To investigate the change in clinical biomarkers measured before and after successful treatment.	From enrollment to 1 year post-treatment.

Collaborators and Investigators

• Sponsor: Danish Headache Center
• Investigators: Principal Investigator: Henrik W Schytz, MD, Ph.D. DMSc, Danish Headache Center

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: PDPH; Post-Dural Puncture Headache; Spontaneous Intracranial Hypotension; SIH; Post-Lumbar Puncture Headache; PLPH; Danish Headache Center
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Headache Disorders; Headache Disorders, Secondary; Headache; Hypotension; Post-Dural Puncture Headache; Intracranial Hypotension
• Other Study ID Numbers: H-24055595; NNF24OC0087919 (Other Grant/Funding Number: Novo Nordisk Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No