Pituitary Function and Spontaneous Intracranial Hypotension

• Sponsor: Cedars-Sinai Medical Center (Other)
• Overall Status: Suspended
• CT.gov ID: NCT02603549
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 65.1
• Patients Per Site Per Month: 1.5

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Mokri B. Cerebrospinal fluid volume depletion and its emerging clinical/imaging syndromes. Neurosurg Focus. 2000 Jul 15;9(1):e6. Review.
• SCHALTENBRAND G. Normal and pathological physiology of the cerebrospinal fluid circulation. Lancet. 1953 Apr 25;1(6765):805-8.
• Schievink WI. Spontaneous spinal cerebrospinal fluid leaks and intracranial hypotension. JAMA. 2006 May 17;295(19):2286-96. Review.

• Responsible Party: Vivien Bonert, MD, Clinical Director, Pituitary Center, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT02603549
• 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: Hyperprolactinemia; Intracranial Hypotension; Hypotension

Study Results

No Results Posted as of Jan 31, 2019