Pituitary Function and Spontaneous Intracranial Hypotension

NCT02603549 | Suspended

• 1 other identifier: Pro39357
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperprolactinemia; Spontaneous Intracranial Hypotension

Outcome Measures

Primary Outcomes (1)

• Comparing the levels of prolactin pre and post treatment

  90 days

Study Arms (1)

Surgery or Blood Patch

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

Interventions

Pituitary panel will be drawn pre-op and post-op for all patients. OTHER

Surgery or Blood Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Spontaneous intracranial hypotension (SIH)

You may qualify if:

• Male or female patients
• Age 18 years and older
• Diagnosis of SIH:
• Brain MRI (SEEPS)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (3)

• Schievink WI. Spontaneous spinal cerebrospinal fluid leaks and intracranial hypotension. JAMA. 2006 May 17;295(19):2286-96. doi: 10.1001/jama.295.19.2286.

  PMID: 16705110 BACKGROUND

• SCHALTENBRAND G. Normal and pathological physiology of the cerebrospinal fluid circulation. Lancet. 1953 Apr 25;1(6765):805-8. doi: 10.1016/s0140-6736(53)91948-5. No abstract available.

  PMID: 13036182 BACKGROUND

• Mokri B. Cerebrospinal fluid volume depletion and its emerging clinical/imaging syndromes. Neurosurg Focus. 2000 Jul 15;9(1):e6. doi: 10.3171/foc.2000.9.1.6.

  PMID: 16859267 BACKGROUND

MeSH Terms

Conditions

Hyperprolactinemia; Intracranial Hypotension

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Vivien Bonert, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director, Pituitary Center

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 13, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

US (1)