Pathophysiological Mechanisms and Implication of Treatment in Postural Puncture Headache

Post-Dural Puncture Headache Clinical Trial

— PDPH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06253754
• Other study ID #: 2024-06754-01
• Status: Recruiting
• Start date: January 30, 2024
• Est. completion date: December 28, 2027

Study information

• Verified date: February 2024
• Source: Umeå University
• Contact: Erik Burman, MD
• Phone: 907864594
• Email: erik.burman[@]regionvasterbotten.se
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 28, 2027
• Est. primary completion date: December 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache

Intervention

Other:
• MRI examination
All included subjects will be examined with MRI

Locations

Country	Name	City	State
Sweden	Umeå University Hospital	Umeå	Västerbotten

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Region Västerbotten

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cerebral dynamics with MRI	Cerebral blood flow and CSF	After 3 months