Hydrocephalus, Normal PressureNCT01115270
A Study Comparing Shunt Placement Versus Endoscopic Third Ventriculostomy in the Treatment of Hydrocephalus
An observational study of Hydrocephalus, Normal Pressure, run by University of California, Los Angeles at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hydrocephalus, Normal Pressure
- What is being tested?
- Non-invasive measures
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized NPH and non-NPH patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hydrocephalus, Normal Pressure
- Being tested
- Non-invasive measures
- Keywords
- Normal Pressure Hydrocephalus
- Medical subject headings
- Hydrocephalus, Normal Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive measuresOther
assessment of cerebrovascular fluid movement
| Study group | Role | What they receive |
|---|---|---|
| Hydrocephalus Patients | Those patients diagnosed with Normal Pressure Hydrocephalus. Receives: Other: Non-invasive measures | |
| Normal Participants | Individuals who are not diagnosed with Normal Pressure Hydrocephalus. Receives: Other: Non-invasive measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracranial compliance
assessment of pulsatile cerbrovascular fluid movement
Measured: 72 hours
Secondary outcomes (1)
cerebrovascular change
neuroimaging
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startFeb 2007
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydrocephalus, Normal PressureStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Marvin Bergsneider, University of California, Los Angeles
- Investigators
- Marvin Bergsneider, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115270
- Sponsor's protocol ID
- 5R01NS054881-04
- Other IDs
- 07-08-038-03
- Status last verified
- May 2016
- First submitted
- 30 Apr 2010
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing Shunt Placement Versus Endoscopic Third Ventriculostomy in the Treatment of Hydrocephalus
- ClinicalTrials.gov ID
- NCT01115270
- Acronym / sponsor ID
- 5R01NS054881-04
- Conditions
- Hydrocephalus, Normal Pressure
- Keywords
- Normal Pressure Hydrocephalus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Feb 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocephalus Patients | – | Other: Non-invasive measuresThose patients diagnosed with Normal Pressure Hydrocephalus. |
| Normal Participants | – | Other: Non-invasive measuresIndividuals who are not diagnosed with Normal Pressure Hydrocephalus. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized NPH and non-NPH patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive measuresassessment of cerebrovascular fluid movement | Other | Hydrocephalus Patients, Normal Participants |
Primary outcome
intracranial compliance
Time frame: 72 hours
assessment of pulsatile cerbrovascular fluid movement
1 secondary outcome
cerebrovascular change
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marvin Bergsneider, M.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus, Normal Pressure, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intracranial compliance (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.