Pituitary Function and Spontaneous Intracranial Hypotension

Suspended

• Conditions: Hyperprolactinemia; Spontaneous Intracranial Hypotension
• Interventions: Other: Pituitary panel will be drawn pre-op and post-op for all patients.

• Registration Number: NCT02603549
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-13
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgery or Blood Patch	Pituitary panel will be drawn pre-op and post-op for all patients.	-

Primary Outcome Measures

Name	Time	Method
Comparing the levels of prolactin pre and post treatment	90 days

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States