Pituitary Function and Spontaneous Intracranial Hypotension

NCT ID: NCT02603549

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Hyperprolactinemia Spontaneous Intracranial Hypotension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgery or Blood Patch

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

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Vivien Bonert, MD

Clinical Director, Pituitary Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vivien Bonert, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16705110 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 13036182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16859267 (View on PubMed)

Other Identifiers

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Pro39357

Identifier Type: -

Identifier Source: org_study_id

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