- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01115270
A Study Comparing Shunt Placement Versus Endoscopic Third Ventriculostomy in the Treatment of Hydrocephalus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The management of normal pressure hydrocephalus (NPH) is challenging due to diagnostic uncertainties and high treatment risks. To date, there are no evidence-based treatment standards for this disorder. Our long-term goal is to improve the outcome of NPH improving our understanding of cerebrospinal fluid (CSF) hydrodynamics. The Specific Aims are to 1) determine the value of a high volume tap test, and 2) determine whether intracranial hemo/hydrodynamic variables, measured before a shunt operation, support the tuned-dynamic absorber model of intracranial pressure dynamics.
The study's Aim relates to modeling the complex hydro- and hemodynamics of intracranial physiology-pathology. We hypothesize that current hydrocephalus models are over-simplistic and that shunt-induced hydrodynamics are better modeled based on ICP waveform characteristics and the application of novel dynamic models. Much of the data for this Aim will be passively recorded during the routine care of the patient. In essence, we are only adding noninvasive MRI studies and TCD (transcranial Doppler) studies.
The experimental methodology is aimed at altering the intracranial compartment compliance by placing the patient in various positions so that these phase differences can be detected. The simplest way to alter intracranial compliance is to make postural changes. When a patient is in the Trendelenburg position, venous outflow out of the brain is hindered resulting in an increase in ICP and presumably a reduction in compliance. Conversely, raising the head of bed to 60 degrees will result in the opposite effect. The second mechanism of altering compliance (and ICP) will occur as a result of treating the hydrocephalus with a CSF shunt. Because we are able to study hydrocephalus patients prior to shunting as part of their diagnostic workup, we create a new state with the shunt that will allow us to further characterize the intracranial system.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA Neurosurgery
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Findings of gait/balance disturbance must be present, plus at least one other area of impairment in cognition, urinary symptoms or both
- Minimum duration of symptoms of at least three months, progression over time, and no other neurological, psychiatric or general medical conditions that are sufficient to explain the presenting symptoms
- MRI or CT performed after onset of symptoms must show evidence of ventricular enlargement (Evan's index > 0.3) not entirely attributable to cerebral atrophy or congenital enlargement
- Criteria for shunt placement: we place greatest emphasis on the results of the temporary CSF drainage trial. Patients who experience a temporary improvement in neurological function (gait, bladder control, and/or cognition) are offered a shunt operation. For patients in whom the CSF drainage results were equivocal, then other factors such as elevated baseline ICP and/or high Rout will also be considered for a shunt under these circumstances
Exclusion Criteria:
- Age < 40
- Fixed musculoskeletal deformities that will exclude gait improvement
- Advanced dementia
- Inability to obtain an MRI study
- General medical conditions in which operative risks are excessive
- Patients taking Warfarin (Coumadin) will be excluded
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hydrocephalus Patients
Those patients diagnosed with Normal Pressure Hydrocephalus.
|
assessment of cerebrovascular fluid movement
|
Normal Participants
Individuals who are not diagnosed with Normal Pressure Hydrocephalus.
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assessment of cerebrovascular fluid movement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intracranial compliance
Time Frame: 72 hours
|
assessment of pulsatile cerbrovascular fluid movement
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cerebrovascular change
Time Frame: 72 hours
|
neuroimaging
|
72 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marvin Bergsneider, M.D., University of California, Los Angeles
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01NS054881-04 (NIH)
- 07-08-038-03 (OTHER_GRANT: IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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