Spontaneous Intracranial HypotensionPATCHESNCT06805591
Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study
An observational study of Spontaneous Intracranial Hypotension and Intracranial Hypotension, run by Danish Headache Center at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spontaneous Intracranial Hypotension, Intracranial Hypotension, Post-Lumbar Puncture Headache
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Dec 2024to 30 Sep 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients at the Danish Headache Center with suspected intracranial hypotension
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- 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
- Medical subject headings
- Intracranial Hypotension, Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
To investigate the change in clinical biomarkers measured before and after successful treatment.
Measured: From enrollment to 1 year post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start10 Dec 2024
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Intracranial HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Schytz, Danish Headache Center
- Investigators
- Henrik W Schytz, MD, Ph.D. DMSc, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805591
- Sponsor's protocol ID
- H-24055595
- Other IDs
- NNF24OC0087919
- Acronym
- PATCHES
- Status last verified
- Feb 2025
- First submitted
- 28 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Imaging Characteristics in Patients Suspected of Dural Leakage Before and After Treatment
- ClinicalTrials.gov ID
- NCT06805591
- Acronym / sponsor ID
- PATCHES / H-24055595
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the Danish Headache Center with suspected intracranial hypotension
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To investigate the change in clinical biomarkers measured before and after successful treatment.
Time frame: From enrollment to 1 year post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Henrik W Schytz, MD, Ph.D. DMSc principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Intracranial Hypotension and Intracranial Hypotension, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the change in clinical biomarkers measured before and after successful treatment. (time frame: From enrollment to 1 year post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.