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Pathophysiological Mechanisms and Implication of Treatment in Postural Puncture Headache (PDPH)

U

Umeå University

Status

Enrolling

Conditions

Post-Dural Puncture Headache

Treatments

Other: MRI examination

Study type

Observational

Funder types

Other

Identifiers

NCT06253754
2024-06754-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

All

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

160 participants in 2 patient groups

Postdural puncture headache after lumbar puncture
Description:
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.
Treatment:
Other: MRI examination
Postdural puncture headache after accidental dural puncture
Description:
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.
Treatment:
Other: MRI examination

Trial contacts and locations

1

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Central trial contact

Erik Burman, MD

Data sourced from clinicaltrials.gov

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