Overview

This trial is active, not recruiting.

Conditions hyperprolactinemia, spontaneous intracranial hypotension
Treatment pituitary panel will be drawn pre-op and post-op for all patients.
Sponsor Cedars-Sinai Medical Center
Start date July 2015
End date July 2017
Trial size 100 participants
Trial identifier NCT02603549, Pro39357

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, we would like to like to assess the clinical manifestations and neuroimaging abnormalities of SIH patients with regard to the pituitary gland. Specifically, we are looking to analyze the compression of the pituitary stalk and conduct a systemic evaluation of pituitary function in SIH patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
pituitary panel will be drawn pre-op and post-op for all patients.

Primary Outcomes

Measure
Comparing the levels of prolactin pre and post treatment
time frame: 90 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Spontaneous Spinal Cerebrospinal Fluid Leaks and Intracranial Hypotension
Principal investigator Vivien Bonert, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Cedars-Sinai Medical Center.