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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Dural Puncture Headache
• Intervention / Treatment: Other: MRI examination

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 Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Erik Burman, MD; Phone Number: +46 907864594; Email: erik.burman@regionvasterbotten.se

Study Locations

• Sweden
  • Västerbotten
    • Umeå, Västerbotten, Sweden
      • Recruiting
      • Umea University Hospital
      • Contact: Laleh Zarrinkoob, MD, PhD; Phone Number: +46 907864594; Email: laleh.zarrinkoob@umu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Two different study population with PDPH and controls.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: MRI examination; All included subjects will be examined with MRI
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.	Other: MRI examination; All included subjects will be examined with MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cerebral dynamics with MRI	Cerebral blood flow and CSF	After 3 months

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Region Västerbotten
• Investigators: Principal Investigator: Laleh Zarrinkoob, MD, PhD, Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): December 28, 2027

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: MRI; Cerebrospinal fluid; Cerebral blood flow
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache
• Other Study ID Numbers: 2024-06754-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No