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

NCT01115270 | Completed DMC

• 2 other identifiers: 5R01NS054881-0407-08-038-03
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus, Normal Pressure

Keywords

Normal Pressure Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• intracranial compliance

  assessment of pulsatile cerbrovascular fluid movement

  72 hours

Secondary Outcomes (1)

• cerebrovascular change

  72 hours

Study Arms (2)

Hydrocephalus Patients

Those patients diagnosed with Normal Pressure Hydrocephalus.

Other: Non-invasive measures

Normal Participants

Individuals who are not diagnosed with Normal Pressure Hydrocephalus.

Other: Non-invasive measures

Interventions

Non-invasive measures OTHER

assessment of cerebrovascular fluid movement

Hydrocephalus Patients; Normal Participants

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized NPH and non-NPH patients

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

UCLA Neurosurgery

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Marvin Bergsneider, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marvin Bergsneider, M.D.

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 4, 2010
• Study Start: February 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 9, 2016

Record last verified: 2016-05

Locations

US (1)