Post-Dural Puncture HeadachePDPHNCT06253754
Pathophysiological Mechanisms and Implication of Treatment in Postural Puncture Headache
An observational study of Post-Dural Puncture Headache, run by Umeå University at 1 site in Sweden.
Trial summary
To improve treatment for post dural puncture headache, its pathophysiology needs to be explored. Dural puncture alters CNS dynamics; using advanced MRI, we aim to investigate PDPHs pathophysiology explained by brain movement, cerebral blood flow, CSF dynamics and the effect of epidural blood patch. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- MRI examination
- How many people
- 160 participants
- Where
- 1 siteSweden
- Study dates
- 30 Jan 2024to 28 Dec 2027
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Two different study population with PDPH and controls.
Who may be able to join
- Postural puncture headache Age 20-40
Who cannot join
- Other central neurological disorders except the actual
- Acute medical condition
- Pregnancy
- Pacemaker, or other medical implants that are not MRI-compatible
- Invasive procedures on the central nervous system or surgery on the spine or brain in the last 12 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Umeå University Hospital
Umeå, Västerbotten County
Laleh Zarrinkoob, MD, PhD, 907864594 ext. +46, laleh.zarrinkoob@umu.se
About this study
Official title: Cerebral Hemodynamics and Cerebrospinal Fluid Dynamics in Postdural Puncture Headache An MRI Study for Exploring the Pathophysiological Mechanisms and Implication of Treatment
To improve treatment for post dural puncture headache, its pathophysiology needs to be explored. Dural puncture alters CNS dynamics; using advanced MRI, we aim to investigate PDPHs pathophysiology explained by brain movement, cerebral blood flow, CSF dynamics and the effect of epidural blood patch.
Read the detailed description
Post dural puncture headache (PDPH) is an iatrogenic and most common serious complication that can occur after a lumbar puncture or accidental dural puncture (ADP), as is often the case in women receiving epidural analgesia (EDA) during labour.
It is linked to substantial distress for patients specially mothers during the postpartum period, resulting in difficulties in forming a satisfying emotional bond with their newborns.
PDPH is a clinical diagnosis, based on symptoms and chronology of events and is therefore subjective since it relies on the patients' descriptions of symptoms and the clinician's interpretation of those symptoms.
Despite the lack of clear understanding of the pathophysiology of PDPH, several treatments have been suggested where an epidural blood patch (EBP) is considered the most effective option. Even though application of an EBP carries risks, symptom-relief is almost instantaneous, and the treatment has been shown to shorten hospital stay.
However, to improve treatment of these patients, a better understanding of its pathophysiology is needed to understand this condition more clearly. Even though PDPH is classified as a low-pressure headache it has been shown that the presence of PDPH does not always relate to a low CSF pressure nor does a normal pressure exclude PDPH. Our hypothesis is that the dural puncture, and the resulting outflow of CSF, changes intracerebral hemodynamics and dynamics of the CSF in a way that has never been fully investigated and described. Using magnet resonance imaging (MRI), including 4D phase contrast MRI it will be possible to quantify changes in hemodynamics and CSF dynamics in a new manner.
The main objective of this study is therefore to investigate the effects of dural puncture on cerebral blood flow (CBF) and cerebrospinal fluid (CSF) volume and pulsation and their relation to PDPH. This project will help to better understand the pathophysiology of PDPH and pave the way for improved management strategies in the future.
- Conditions
- Post-Dural Puncture Headache
- Being tested
- MRI examination
- Keywords
- MRI, Cerebral blood flow, Cerebrospinal fluid
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examinationOther
All included subjects will be examined with MRI
| Study group | Role | What they receive |
|---|---|---|
| Postdural puncture headache after lumbar puncture | Group of patients with aged 20-40 years undergoing planned neurological work-up including a lumbar puncture (LP). The group will include 40 subjects with and 40 subjects without PDPH. Receives: Other: MRI examination | |
| Postdural puncture headache after accidental dural puncture | Group of parturients with EDA. The group will include 40 subjects with accidental dural puncture (ADP) with PDPH and 40 subjects without ADP and PDPH. Receives: Other: MRI examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cerebral dynamics with MRI
Cerebral blood flow and CSF
Measured: After 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start30 Jan 2024
- Primary completion28 Dec 2027 (estimated)
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Dural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västerbotten
- Responsible party
- Sponsor
- Investigators
- Laleh Zarrinkoob, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253754
- Sponsor's protocol ID
- 2024-06754-01
- Acronym
- PDPH
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Hemodynamics and Cerebrospinal Fluid Dynamics in Postdural Puncture Headache An MRI Study for Exploring the Pathophysiological Mechanisms and Implication of Treatment
- ClinicalTrials.gov ID
- NCT06253754
- Acronym / sponsor ID
- PDPH / 2024-06754-01
- Conditions
- Post-Dural Puncture Headache
- Keywords
- MRI, Cerebral blood flow, Cerebrospinal fluid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Västerbotten
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 28 Dec 2027 (estimated)
- First posted
- 12 Feb 2024 (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.
To improve treatment for post dural puncture headache, its pathophysiology needs to be explored. Dural puncture alters CNS dynamics; using advanced MRI, we aim to investigate PDPHs pathophysiology explained by brain movement, cerebral blood flow, CSF dynamics and the effect of epidural blood patch.
Detailed description
Post dural puncture headache (PDPH) is an iatrogenic and most common serious complication that can occur after a lumbar puncture or accidental dural puncture (ADP), as is often the case in women receiving epidural analgesia (EDA) during labour.
It is linked to substantial distress for patients specially mothers during the postpartum period, resulting in difficulties in forming a satisfying emotional bond with their newborns.
PDPH is a clinical diagnosis, based on symptoms and chronology of events and is therefore subjective since it relies on the patients' descriptions of symptoms and the clinician's interpretation of those symptoms.
Despite the lack of clear understanding of the pathophysiology of PDPH, several treatments have been suggested where an epidural blood patch (EBP) is considered the most effective option. Even though application of an EBP carries risks, symptom-relief is almost instantaneous, and the treatment has been shown to shorten hospital stay.
However, to improve treatment of these patients, a better understanding of its pathophysiology is needed to understand this condition more clearly. Even though PDPH is classified as a low-pressure headache it has been shown that the presence of PDPH does not always relate to a low CSF pressure nor does a normal pressure exclude PDPH. Our hypothesis is that the dural puncture, and the resulting outflow of CSF, changes intracerebral hemodynamics and dynamics of the CSF in a way that has never been fully investigated and described. Using magnet resonance imaging (MRI), including 4D phase contrast MRI it will be possible to quantify changes in hemodynamics and CSF dynamics in a new manner.
The main objective of this study is therefore to investigate the effects of dural puncture on cerebral blood flow (CBF) and cerebrospinal fluid (CSF) volume and pulsation and their relation to PDPH. This project will help to better understand the pathophysiology of PDPH and pave the way for improved management strategies in the future.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postdural puncture headache after lumbar puncture | – | Other: MRI examinationGroup of patients with aged 20-40 years undergoing planned neurological work-up including a lumbar puncture (LP). The group will include 40 subjects with and 40 subjects without PDPH. |
| Postdural puncture headache after accidental dural puncture | – | Other: MRI examinationGroup of parturients with EDA. The group will include 40 subjects with accidental dural puncture (ADP) with PDPH and 40 subjects without ADP and PDPH. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Two different study population with PDPH and controls.
Key inclusion criteria (1 listed)
- Postural puncture headache Age 20-40
Key exclusion criteria (5 listed)
- Other central neurological disorders except the actual
- Acute medical condition
- Pregnancy
- Pacemaker, or other medical implants that are not MRI-compatible
- Invasive procedures on the central nervous system or surgery on the spine or brain in the last 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI examinationAll included subjects will be examined with MRI | Other | Postdural puncture headache after accidental dural puncture, Postdural puncture headache after lumbar puncture |
Primary outcome
Changes in cerebral dynamics with MRI
Time frame: After 3 months
Cerebral blood flow and CSF
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 12 Feb 2024.
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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.
Laleh Zarrinkoob, MD, PhD principal investigator
Umeå University
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 Post-Dural Puncture Headache, run by Umeå University at 1 site in Sweden.
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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Feb 2024. 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 Sweden. 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?
Contact Erik Burman, MD (907864594 ext. +46, erik.burman@regionvasterbotten.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cerebral dynamics with MRI (time frame: After 3 months). 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 12 Feb 2024.