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A Study Comparing Shunt Placement Versus Endoscopic Third Ventriculostomy in the Treatment of Hydrocephalus

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ClinicalTrials.gov Identifier: NCT01115270
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : May 9, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
The main purpose of this study is to compare two types of treatment of hydrocephalus: placement of a ventriculoperitoneal (VP) shunt versus an endoscopic third ventriculostomy (ETV). A second goal of this study will be to understand how the two different types of procedures, VP shunt versus ETV, affect brain blood flow and pressures. Understanding these changes is important because the investigators hope is to someday be able to predict who will better respond to one procedure or another.

Condition or disease Intervention/treatment
Hydrocephalus, Normal Pressure Other: Non-invasive measures

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 Design

Study Type : Observational
Actual Enrollment : 196 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Study Comparing Shunt Placement Versus Endoscopic Third Ventriculostomy in the Treatment of Hydrocephalus
Study Start Date : February 2007
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Hydrocephalus Patients
Those patients diagnosed with Normal Pressure Hydrocephalus.
Other: Non-invasive measures
assessment of cerebrovascular fluid movement
Normal Participants
Individuals who are not diagnosed with Normal Pressure Hydrocephalus.
Other: Non-invasive measures
assessment of cerebrovascular fluid movement

Outcome Measures

Primary Outcome Measures :
  1. intracranial compliance [ Time Frame: 72 hours ]
    assessment of pulsatile cerbrovascular fluid movement

Secondary Outcome Measures :
  1. cerebrovascular change [ Time Frame: 72 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized NPH and non-NPH patients

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115270

United States, California
UCLA Neurosurgery
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Marvin Bergsneider, M.D. University of California, Los Angeles
More Information

Responsible Party: Marvin Bergsneider, Marvin Bergsneider, M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01115270     History of Changes
Other Study ID Numbers: 5R01NS054881-04 ( U.S. NIH Grant/Contract )
07-08-038-03 ( Other Grant/Funding Number: IRB )
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: May 9, 2016
Last Verified: May 2016

Keywords provided by Marvin Bergsneider, University of California, Los Angeles:
Normal Pressure Hydrocephalus

Additional relevant MeSH terms:
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases