Pituitary Function and Spontaneous Intracranial Hypotension

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Brief Title

Pituitary Function and Spontaneous Intracranial Hypotension

Official Title

Spontaneous Spinal Cerebrospinal Fluid Leaks and Intracranial Hypotension

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.
    



Study Type

Observational


Primary Outcome

Comparing the levels of prolactin pre and post treatment


Condition

Hyperprolactinemia

Intervention

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

Study Arms / Comparison Groups

 Surgery or Blood Patch
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

100

Start Date

July 2015

Completion Date

December 2020

Primary Completion Date

December 2020

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Vivien Bonert, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02603549

Organization ID

Pro39357


Responsible Party

Principal Investigator

Study Sponsor

Cedars-Sinai Medical Center


Study Sponsor

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


Verification Date

January 2019