Pituitary Function and Spontaneous Intracranial Hypotension

Hyperprolactinemia Clinical Trial

Official title:

Spontaneous Spinal Cerebrospinal Fluid Leaks and Intracranial Hypotension

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02603549
• Other study ID #: Pro39357
• Status: Suspended
• Start date: July 2015
• Est. completion date: December 2020

Study information

• Verified date: January 2019
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperprolactinemia
• Hypotension
• Intracranial Hypotension
• Spontaneous Intracranial Hypotension

Intervention

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

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Mokri B. Cerebrospinal fluid volume depletion and its emerging clinical/imaging syndromes. Neurosurg Focus. 2000 Jul 15;9(1):e6. Review. — View Citation

SCHALTENBRAND G. Normal and pathological physiology of the cerebrospinal fluid circulation. Lancet. 1953 Apr 25;1(6765):805-8. — View Citation

Schievink WI. Spontaneous spinal cerebrospinal fluid leaks and intracranial hypotension. JAMA. 2006 May 17;295(19):2286-96. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing the levels of prolactin pre and post treatment		90 days