Pituitary Function and Spontaneous Intracranial Hypotension

January 29, 2019 updated by: Vivien Bonert, MD, Cedars-Sinai Medical Center

Spontaneous Spinal Cerebrospinal Fluid Leaks and Intracranial Hypotension

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 Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Spontaneous intracranial hypotension (SIH)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgery or Blood Patch
Other: Pituitary panel will be drawn pre-op and post-op for all patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparing the levels of prolactin pre and post treatment
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 10, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro39357

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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