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Completed

NCT Number: NCT01115270

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA Neurosurgery

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive measures

Other

assessment of cerebrovascular fluid movement

Primary outcomes

  1. intracranial compliance

    Time frame: 72 hours

    assessment of pulsatile cerbrovascular fluid movement

Secondary outcomes

  1. cerebrovascular change

    Time frame: 72 hours

    neuroimaging

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 4, 2010
Registry last updated
May 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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