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NCT Number: NCT06253754

Pathophysiological Mechanisms and Implication of Treatment in Postural Puncture Headache

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Umeå University Hospital

Umeå, Västerbotten County, Sweden

Location status: Recruiting

Location contact

Laleh Zarrinkoob, MD, PhD

CONTACT

[email protected]

907864594 ext. +46

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Postural puncture headache Age 20-40

Exclusion criteria

  • 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.

Treatment and study plan

MRI examination

Other

All included subjects will be examined with MRI

Primary outcomes

  1. Changes in cerebral dynamics with MRI

    Time frame: After 3 months

    Cerebral blood flow and CSF

Study contacts

Contact information is provided by the study sponsor or research team.

Erik Burman, MD

CONTACT

[email protected]

907864594 ext. +46

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Region Västerbotten

Registry information

Official study title

Cerebral Hemodynamics and Cerebrospinal Fluid Dynamics in Postdural Puncture Headache An MRI Study for Exploring the Pathophysiological Mechanisms and Implication of Treatment

Acronym: PDPH

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2024
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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