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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01115270
First received: April 30, 2010
Last updated: May 3, 2010
Last verified: April 2010
  Purpose

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 Intervention
Hydrocephalus, Normal Pressure
Other: Non-invasive measures

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Study Comparing Shunt Placement Versus Endoscopic Third Ventriculostomy in the Treatment of Hydrocephalus

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • intracranial compliance [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    assessment of pulsatile cerbrovascular fluid movement


Secondary Outcome Measures:
  • cerebrovascular change [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    neuroimaging


Estimated Enrollment: 500
Study Start Date: February 2007
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitalized NPH and non-NPH patients

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115270

Contacts
Contact: Marvin Bergsneider, M.D. 310-206-4100 MBergsneider@mednet.ucla.edu
Contact: Adrian Ibarra 310-206-4100 AIbarra@mednet.ucla.edu

Locations
United States, California
UCLA Neurosurgery Recruiting
Los Angeles, California, United States, 90095
Contact: Marvin Bergsneider, M.D.    310-206-4100    MBergsneider@mednet.ucla.edu   
Contact: Adrian Ibarra    310-206-4100    AIbarra@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Marvin Bergsneider, M.D. University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Marvin Bergsneider, M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01115270     History of Changes
Other Study ID Numbers: 5R01NS054881-04, 07-08-038-03
Study First Received: April 30, 2010
Last Updated: May 3, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 21, 2014