NCT06253754

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Jan 2024Dec 2027

Study Start

First participant enrolled

January 30, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2027

Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

3.9 years

First QC Date

February 1, 2024

Last Update Submit

February 9, 2024

Conditions

Post-Dural Puncture Headache

Keywords

MRICerebral blood flowCerebrospinal fluid

Outcome Measures

Primary Outcomes (1)

  • Changes in cerebral dynamics with MRI

    Cerebral blood flow and CSF

    After 3 months

Study Arms (2)

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

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

Interventions

MRI examinationOTHER

All included subjects will be examined with MRI

Postdural puncture headache after accidental dural puncturePostdural puncture headache after lumbar puncture

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Two different study population with PDPH and controls.

You may qualify if:

  • Postural puncture headache Age 20-40

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå University Hospital

Umeå, Västerbotten County, Sweden

RECRUITING

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Laleh Zarrinkoob, MD, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik Burman, MD

CONTACT

907864594erik.burman@regionvasterbotten.se

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 12, 2024

Study Start

January 30, 2024

Primary Completion (Estimated)

December 28, 2027

Study Completion (Estimated)

December 28, 2027

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations

SE(1)