HydrocephalusNCT00946127
ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus
An observational study of Hydrocephalus, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to test and compare the efficacy of Endoscopic Third Ventriculostomy with shunting of Cerebrospinal fluid (CSF)for treatment for patients of Normal pressure Hydrocephalus. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Ventriculoperitoneal Shunt Placement and Endoscopic Third Ventriculostomy(ETV)
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suspected of Normal pressure hydrocephalus i.e. - with gait disturbances and/ or cognitive disturbances and/or urinary incontinence with dilation of ventricles on CT or MRI.
Who may be able to join
- Patients with NPH
- Meet at least 2 of 3 Hakim and Adams diagnostic criterion for NPH (dementia, gait instability and urinary incontinence)
- Ventriculomegaly defined by CT or MRI, Evans' index > 0.3
- Clinical improvement after 3 day trial of CSF drainage.
- MMSE>24
- Informed consent from patient
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Third Ventriculostomy (ETV) Versus Ventriculoperitoneal Shunting (VPS) for the Surgical Management of Normal Pressure Hydrocephalus
The purpose of this study is to test and compare the efficacy of Endoscopic Third Ventriculostomy with shunting of Cerebrospinal fluid (CSF)for treatment for patients of Normal pressure Hydrocephalus.
Read the detailed description
Normal pressure Hydrocephalus is a reversible disorder of cognition and gait disorder.Currently the shunting of CSF is the recommended treatment of these patients. Even though shunts are known to be beneficial treatment of Hydrocephalus they often need treatment or revision for infection or malfunction. Endoscopic Third Ventriculostomy is a treatment without complications of shunt and is known to benefit obstructive forms of hydrocephalus.Few studies have also shown that it may be efficacious treatment Normal pressure Hydrocephalus.
- Conditions
- Hydrocephalus
- Being tested
- Ventriculoperitoneal Shunt Placement, Endoscopic Third Ventriculostomy(ETV)
- Keywords
- Normal Pressure Hydrocephalus, Communicating Hydrocephalus, Gait disorder, Cognition, Shunt, Endoscopic Third Ventriculostomy.
- Medical subject headings
- Hydrocephalus, Hydrocephalus, Normal Pressure, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventriculoperitoneal Shunt PlacementProcedure or surgery
Also called Hydrocephalus Shunt Component - Catheter-manufacturer- Medtronic Neurosurgery Inc, Codman and Hakim Shunt System--manufacturer-Codman & Shurtleff, Inc., Medtronic PS Polyurethane Shunt--manufacturer-Medtronic Neurosurgery Inc, Miethke proGAV shunt system-manufacturer- Aesculap Inc
In the subjects who choose this arm, at the start of study- CSF (Cerebrospinal fluid ) will be shunted to peritoneum by placing a ventriculoperitoneal shunt catheter with or without shunt valves or anti-siphon device.
Endoscopic Third Ventriculostomy(ETV)Procedure or surgery
Patients who choose to undergo ETV arm would undergo a ventriculostomy at the start of study.
| Study group | Role | What they receive |
|---|---|---|
| Shunt Arm | Ventriculoperitoneal Shunt Receives: Procedure: Ventriculoperitoneal Shunt Placement | |
| ETV arm | Endoscopic Third Ventriculostomy Receives: Procedure: Endoscopic Third Ventriculostomy(ETV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Cognitive outcomes using RAVLT scale. Gait Outcomes evaluated based on Tinneti Gait and Balance Test. Functional Independence evaluated using Barthel index.
Measured: 1, 3, 6, 12 months after surgery
Safety
Incidence of operative complications related to insertion of a shunt or performing ETV Intra-operative hemorrhage Post Operative amnesia Post Operative hemorrhage Infections Others Incidence of complications related to either of the two procedure over long term follow-up Infection Shunt malfunction ETV closure Others
Measured: 0 through 12 months from Surgery
Secondary outcomes (1)
Efficacy: Cognitive changes using Trails A& B. Gait changes based upon Timed Up and Go task and Gait Rite analysis.
Measured: 1 months, 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Unable to recruit patients and lack of efficacy in ETV arm
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Rigamonti, Johns Hopkins University
- Investigators
- Daniele Rigamonti, MD, FACS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946127
- Sponsor's protocol ID
- NA_00014030
- Status last verified
- Oct 2012
- First submitted
- 23 Jul 2009
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Gangemi M, Maiuri F, Buonamassa S, Colella G, de Divitiis E. Endoscopic third ventriculostomy in idiopathic normal pressure hydrocephalus. Neurosurgery. 2004 Jul;55(1):129-34; discussion 134. doi: 10.1227/01.neu.0000126938.12817.dc.
PubMed 15214981Gangemi M, Maiuri F, Naddeo M, Godano U, Mascari C, Broggi G, Ferroli P. Endoscopic third ventriculostomy in idiopathic normal pressure hydrocephalus: an Italian multicenter study. Neurosurgery. 2008 Jul;63(1):62-7; discussion 67-9. doi: 10.1227/01.NEU.0000335071.37943.40.
PubMed 18728569Pujari S, Kharkar S, Metellus P, Shuck J, Williams MA, Rigamonti D. Normal pressure hydrocephalus: long-term outcome after shunt surgery. J Neurol Neurosurg Psychiatry. 2008 Nov;79(11):1282-6. doi: 10.1136/jnnp.2007.123620. Epub 2008 Mar 20.
PubMed 18356257Dusick JR, McArthur DL, Bergsneider M. Success and complication rates of endoscopic third ventriculostomy for adult hydrocephalus: a series of 108 patients. Surg Neurol. 2008 Jan;69(1):5-15. doi: 10.1016/j.surneu.2007.08.024.
PubMed 18054606Longatti PL, Fiorindi A, Martinuzzi A. Failure of endoscopic third ventriculostomy in the treatment of idiopathic normal pressure hydrocephalus. Minim Invasive Neurosurg. 2004 Dec;47(6):342-5. doi: 10.1055/s-2004-830128.
PubMed 15674750McGirt MJ, Woodworth G, Coon AL, Thomas G, Williams MA, Rigamonti D. Diagnosis, treatment, and analysis of long-term outcomes in idiopathic normal-pressure hydrocephalus. Neurosurgery. 2005 Oct;57(4):699-705; discussion 699-705. doi: 10.1093/neurosurgery/57.4.699.
PubMed 16239882
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Third Ventriculostomy (ETV) Versus Ventriculoperitoneal Shunting (VPS) for the Surgical Management of Normal Pressure Hydrocephalus
- ClinicalTrials.gov ID
- NCT00946127
- Acronym / sponsor ID
- NA_00014030
- Conditions
- Hydrocephalus
- Keywords
- Normal Pressure Hydrocephalus, Communicating Hydrocephalus, Gait disorder, Cognition, Shunt, Endoscopic Third Ventriculostomy.
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to recruit patients and lack of efficacy in ETV arm
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 24 Jul 2009 (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 purpose of this study is to test and compare the efficacy of Endoscopic Third Ventriculostomy with shunting of Cerebrospinal fluid (CSF)for treatment for patients of Normal pressure Hydrocephalus.
Detailed description
Normal pressure Hydrocephalus is a reversible disorder of cognition and gait disorder.Currently the shunting of CSF is the recommended treatment of these patients. Even though shunts are known to be beneficial treatment of Hydrocephalus they often need treatment or revision for infection or malfunction. Endoscopic Third Ventriculostomy is a treatment without complications of shunt and is known to benefit obstructive forms of hydrocephalus.Few studies have also shown that it may be efficacious treatment Normal pressure Hydrocephalus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shunt Arm | – | Procedure: Ventriculoperitoneal Shunt PlacementVentriculoperitoneal Shunt |
| ETV arm | – | Procedure: Endoscopic Third Ventriculostomy(ETV)Endoscopic Third Ventriculostomy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suspected of Normal pressure hydrocephalus i.e. - with gait disturbances and/ or cognitive disturbances and/or urinary incontinence with dilation of ventricles on CT or MRI.
Key inclusion criteria (6 listed)
- Patients with NPH
- Meet at least 2 of 3 Hakim and Adams diagnostic criterion for NPH (dementia, gait instability and urinary incontinence)
- Ventriculomegaly defined by CT or MRI, Evans' index > 0.3
- Clinical improvement after 3 day trial of CSF drainage.
- MMSE>24
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ventriculoperitoneal Shunt PlacementAlso: Hydrocephalus Shunt Component - Catheter-manufacturer- Medtronic Neurosurgery Inc, Codman and Hakim Shunt System--manufacturer-Codman & Shurtleff, Inc., Medtronic PS Polyurethane Shunt--manufacturer-Medtronic Neurosurgery Inc, Miethke proGAV shunt system-manufacturer- Aesculap IncIn the subjects who choose this arm, at the start of study- CSF (Cerebrospinal fluid ) will be shunted to peritoneum by placing a ventriculoperitoneal shunt catheter with or without shunt valves or anti-siphon device. | Procedure or surgery | Shunt Arm |
| Endoscopic Third Ventriculostomy(ETV)Patients who choose to undergo ETV arm would undergo a ventriculostomy at the start of study. | Procedure or surgery | ETV arm |
Primary outcome
Efficacy: Cognitive outcomes using RAVLT scale. Gait Outcomes evaluated based on Tinneti Gait and Balance Test. Functional Independence evaluated using Barthel index.
Time frame: 1, 3, 6, 12 months after surgery
Safety
Time frame: 0 through 12 months from Surgery
Incidence of operative complications related to insertion of a shunt or performing ETV Intra-operative hemorrhage Post Operative amnesia Post Operative hemorrhage Infections Others Incidence of complications related to either of the two procedure over long term follow-up Infection Shunt malfunction ETV closure Others
1 secondary outcome
Efficacy: Cognitive changes using Trails A& B. Gait changes based upon Timed Up and Go task and Gait Rite analysis.
Time frame: 1 months, 3 months, 6 months and 1 year
Results and safety
The study was stopped early (reason given: Unable to recruit patients and lack of efficacy in ETV arm). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
- Background: PubMed 15214981Gangemi M, Maiuri F, Buonamassa S, Colella G, de Divitiis E. Endoscopic third ventriculostomy in idiopathic normal pressure hydrocephalus. Neurosurgery. 2004 Jul;55(1):129-34; discussion 134. doi: 10.1227/01.neu.0000126938.12817.dc.
- Background: PubMed 18728569Gangemi M, Maiuri F, Naddeo M, Godano U, Mascari C, Broggi G, Ferroli P. Endoscopic third ventriculostomy in idiopathic normal pressure hydrocephalus: an Italian multicenter study. Neurosurgery. 2008 Jul;63(1):62-7; discussion 67-9. doi: 10.1227/01.NEU.0000335071.37943.40.
- Background: PubMed 18356257Pujari S, Kharkar S, Metellus P, Shuck J, Williams MA, Rigamonti D. Normal pressure hydrocephalus: long-term outcome after shunt surgery. J Neurol Neurosurg Psychiatry. 2008 Nov;79(11):1282-6. doi: 10.1136/jnnp.2007.123620. Epub 2008 Mar 20.
- Background: PubMed 18054606Dusick JR, McArthur DL, Bergsneider M. Success and complication rates of endoscopic third ventriculostomy for adult hydrocephalus: a series of 108 patients. Surg Neurol. 2008 Jan;69(1):5-15. doi: 10.1016/j.surneu.2007.08.024.
- Background: PubMed 15674750Longatti PL, Fiorindi A, Martinuzzi A. Failure of endoscopic third ventriculostomy in the treatment of idiopathic normal pressure hydrocephalus. Minim Invasive Neurosurg. 2004 Dec;47(6):342-5. doi: 10.1055/s-2004-830128.
- Background: PubMed 16239882McGirt MJ, Woodworth G, Coon AL, Thomas G, Williams MA, Rigamonti D. Diagnosis, treatment, and analysis of long-term outcomes in idiopathic normal-pressure hydrocephalus. Neurosurgery. 2005 Oct;57(4):699-705; discussion 699-705. doi: 10.1093/neurosurgery/57.4.699.
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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.
Daniele Rigamonti, MD, FACS principal investigator
Johns Hopkins University
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, run by Johns Hopkins University 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 6 inclusion and 0 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: stopped early, as of the sponsor's last update on 3 Oct 2012. 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 was stopped early (reason given: Unable to recruit patients and lack of efficacy in ETV arm). Results are not available in the source record.
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?
Efficacy: Cognitive outcomes using RAVLT scale. Gait Outcomes evaluated based on Tinneti Gait and Balance Test. Functional Independence evaluated using Barthel index. (time frame: 1, 3, 6, 12 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00946127, which also lists 6 linked publications.
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 3 Oct 2012.