Pituitary Function and Spontaneous Intracranial Hypotension

Cedars-Sinai Medical Center (Other)
Overall Status
CT.gov ID

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pituitary panel will be drawn pre-op and post-op for all patients.

Study Design

Study Type:
Anticipated Enrollment :
100 participants
Observational Model:
Time Perspective:
Official Title:
Spontaneous Spinal Cerebrospinal Fluid Leaks and Intracranial Hypotension
Study Start Date :
Jul 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Surgery or Blood Patch

Other: Pituitary panel will be drawn pre-op and post-op for all patients.

Outcome Measures

Primary Outcome Measures

  1. Comparing the levels of prolactin pre and post treatment [90 days]

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Male or female patients

  • Age 18 years and older

  • Diagnosis of SIH:

  • LP

  • Brain MRI (SEEPS)

Exclusion Criteria:
  • 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

Contacts and Locations


Site City State Country Postal Code
1 Cedars-Sinai Medical Center Los Angeles California United States 90048

Sponsors and Collaborators

  • Cedars-Sinai Medical Center


  • Principal Investigator: Vivien Bonert, MD, Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information


Responsible Party:
Vivien Bonert, MD, Clinical Director, Pituitary Center, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • Pro39357
First Posted:
Nov 13, 2015
Last Update Posted:
Jan 31, 2019
Last Verified:
Jan 1, 2019
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2019