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

Completed

Conditions studied: Hydrocephalus, Normal Pressure

In brief

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.

Key facts

Study ID

NCT01115270

Run by

University of California, Los Angeles

People needed

196

Starts

2007-02-01

Expected to finish

2011-10-01

Last updated by the study team

2016-05-09

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA Neurosurgery — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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