跳至主要内容
临床试验/NCT02603549
NCT02603549暂停不适用

Spontaneous Spinal Cerebrospinal Fluid Leaks and Intracranial Hypotension

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
100
试验地点
1
主要终点
Comparing the levels of prolactin pre and post treatment

研究概览

简要总结

Previous research has identified spontaneous cerebral spinal fluid leakage as a cause for spontaneous intracranial hypotension, leading to positional headache patterns. Typical magnetic resonance imaging findings include subdural fluid collections, enhancement of pachymenginges, engorgement of venous structures, pituitary hyperemia, and sagging of the brain (SEEPS). Because pituitary hyperemia has been documented in cases of spontaneous cerebral spinal fluid leakage and is known to mimic a pituitary tumor or hyperplasia, the investigators would like to like to assess the clinical manifestations and neuroimaging abnormalities of SIH patients with regard to the pituitary gland. Specifically, the investigators are looking to analyze the compression of the pituitary stalk and conduct a systemic evaluation of pituitary function in SIH patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female patients
  • Age 18 years and older
  • Diagnosis of SIH:
  • Brain MRI (SEEPS)

排除标准

  • Pregnant and post-partum females
  • Nursing mothers
  • Patients with potential hyperprolactinemia due to:
  • Hypothyroidism,
  • Chronic renal disorder
  • Liver disease (including cirrhosis)
  • Primary or secondary amenorrhea
  • Polycystic Ovary Syndrome
  • Seizure disorder
  • Illicit drug use

结局指标

主要结局

Comparing the levels of prolactin pre and post treatment

时间窗: 90 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vivien Bonert, MD

Clinical Director, Pituitary Center

Cedars-Sinai Medical Center

研究点 (1)

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