Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study

NCT06805591 | Enrolling By Invitation

• 2 other identifiers: H-24055595NNF24OC0087919
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

Spontaneous Intracranial Hypotension; SIH; Post-Lumbar Puncture Headache; PLPH; Danish Headache Center; Post-Dural Puncture Headache; PDPH

Outcome Measures

Primary Outcomes (1)

• To investigate the change in clinical biomarkers measured before and after successful treatment.

  From enrollment to 1 year post-treatment.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at the Danish Headache Center with suspected intracranial hypotension

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, Copenhagen, 2600, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and cerebrospinal fluid

MeSH Terms

Conditions

Intracranial Hypotension; Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Secondary; Headache Disorders

Study Officials

• Henrik W Schytz, MD, Ph.D. DMSc

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Consultant Neurologist

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: December 10, 2024
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

DK (1)