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Sponsors and Collaborators: |
Johns Hopkins University Eli Lilly and Company |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00149721 |
Hydrocephalus (secondary or idiopathic) is a condition characterized by dilatation of the lateral and third ventricles, and often associated with increased intracranial pressure (ICP). We hypothesize that either the ventricle dilatation or the increased ICP may cause disturbances in the hypothalamic-pituitary axis, resulting in different degrees of hypopituitarism. The goal of this study is to determine the prevalence of hypopituitarism in adult patients with hydrocephalus.
Condition | Intervention |
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Normal Pressure Hydrocephalus |
Procedure: Ventriculo-peritonal shunting |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study |
Official Title: | Anterior Pituitary Function in Patients With Hydrocephalus |
Estimated Enrollment: | 30 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | December 2007 |
The Johns Hopkins Adult Hydrocephalus Program evaluates approximately 250 new patients per year for hydrocephalus and associated disorders, resulting in the new diagnosis of hydrocephalus in about 100 patients annually. After treatment with either shunt surgery or third ventriculostomy, virtually all patients are followed on a regular basis by physicians in the program (Dr. Michael Williams, neurologist, and Dr. Daniele Rigamonti, neurosurgeon, both involved in this project).
These patients represent an ideal cohort to study the effect of hydrocephalus on anterior pituitary function. In addition, as data on intracranial pressure is available for all of them, evaluation of pituitary function would allow us to determine whether the level of intracranial pressure correlates with the likelihood of pituitary failure.
We propose to study 20 subjects of both sexes with NPH, aged 18-80 years over a period of 18 months. They will be recruited by direct advertising among the patients cared for by the Adult Hydrocephalus Program. Patients with hydrocephalus will be studied twice (6-12 months apart) whether or not they undergo shunting.
STUDY PROTOCOL:
Subjects who have shunt surgery will undergo a second study of pituitary function not earlier than 6 months and no later than 1 year from the procedure. We will identify the degree of clinical improvement by documenting change in gait with the Tinetti Gait Assessment Tool, and change in dementia with the Mini-Mental-Status exam. If there is sufficient sample size in the clinically improved and unimproved patients, we will compare between-group results.
Patients who have been on systemic glucocorticoids (GC) for longer than 3 weeks during the previous 12 months will be excluded, as GC may cause suppression of hypothalamic-adrenal axis. In subjects who are on phenytoin, unbound T4 will be measured by equilibrium dialysis, as phenytoin may interfere with direct unbound T4 measurement. Subjects already on L-thyroxine replacement will be excluded.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of idiopathic hydrocephalus, made by clinical and CT or MRI imaging demonstrating ventricular dilation, and confirmed by an established protocol of continuous CSF drainage via spinal catheter. Patients who are found to be eligible for VP shunt insertion on the basis of improvement in cognition/psychomotor speed, gait, or urinary continence are referred for surgery
Exclusion Criteria:
Known peripheral gland failure (primary hypogonadism, primary adrenal insufficiency, primary hypothyroidism); known history of pituitary tumor, pituitary surgery, pituitary hemorrhage, brain irradiation, or of identified causes of secondary hydrocephalus (subarachnoidal bleeding, meningitis, encephalitis, head trauma).
United States, Maryland | |
GCRC Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Roberto Salvatori, MD | Johns Hopkins University |
Study ID Numbers: | B9R-US-X041 |
Study First Received: | September 7, 2005 |
Last Updated: | January 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00149721 |
Health Authority: | United States: Federal Government |
hydrocephalus pituitary function shunting |
Pseudotumor cerebri Pseudotumor Cerebri Infant, Newborn, Diseases Central Nervous System Diseases Hydrocephalus, Normal Pressure |
Hydrocephalus Brain Diseases Intracranial Hypertension Hypertension |
Nervous System Diseases |