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临床试验/NCT06253754
NCT06253754招募中不适用

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

Umeå University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
1
主要终点
Changes in cerebral dynamics with MRI

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Postural puncture headache Age 20-40

排除标准

  • 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.

结局指标

主要结局

Changes in cerebral dynamics with MRI

时间窗: After 3 months

Cerebral blood flow and CSF

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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