Spontaneous Spinal Cerebrospinal Fluid Leaks and Intracranial Hypotension
| Registry | NCT02603549 |
|---|---|
| Status | Suspended - Study protocol needs to be amended. Recruitment is halted until amendment is completed and approved by IRB. |
| Study type | Observational |
| Enrollment | 100 (Estimated) |
| Sponsor | Cedars-Sinai Medical Center (Other) |
| Conditions | Hyperprolactinemia, Spontaneous Intracranial Hypotension |
| Interventions | Pituitary panel will be drawn pre-op and post-op for all patients. (Other) |
| Dates | start 2015-07-01, primary completion 2020-12-01 (estimated), completion 2020-12-01 (estimated), first posted 2015-11-13, last updated 2019-01-31 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Hyperprolactinemia All trials for Spontaneous Intracranial Hypotension All trials of Pituitary panel will be drawn pre-op and post-op for all patients.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Surgery or Blood Patch | Other: Pituitary panel will be drawn pre-op and post-op for all patients. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles, California | United States |