ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus
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ClinicalTrials.gov Identifier: NCT00946127 |
Recruitment Status :
Terminated
(Unable to recruit patients and lack of efficacy in ETV arm)
First Posted : July 24, 2009
Last Update Posted : October 3, 2012
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Condition or disease | Intervention/treatment |
---|---|
Hydrocephalus | Procedure: Ventriculoperitoneal Shunt Placement Procedure: Endoscopic Third Ventriculostomy(ETV) |
Study Type : | Observational |
Actual Enrollment : | 13 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Endoscopic Third Ventriculostomy (ETV) Versus Ventriculoperitoneal Shunting (VPS) for the Surgical Management of Normal Pressure Hydrocephalus |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | October 2011 |

Group/Cohort | Intervention/treatment |
---|---|
Shunt Arm
Ventriculoperitoneal Shunt
|
Procedure: Ventriculoperitoneal Shunt Placement
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.
Other Names:
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ETV arm
Endoscopic Third Ventriculostomy
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Procedure: Endoscopic Third Ventriculostomy(ETV)
Patients who choose to undergo ETV arm would undergo a ventriculostomy at the start of study. |
- 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
- 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 ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946127
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Daniele Rigamonti, MD, FACS | Johns Hopkins University |
Publications:
Responsible Party: | Daniele Rigamonti, Professor, Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00946127 History of Changes |
Other Study ID Numbers: |
NA_00014030 |
First Posted: | July 24, 2009 Key Record Dates |
Last Update Posted: | October 3, 2012 |
Last Verified: | October 2012 |
Keywords provided by Daniele Rigamonti, Johns Hopkins University:
Normal Pressure Hydrocephalus Communicating Hydrocephalus Gait disorder |
Cognition Shunt Endoscopic Third Ventriculostomy. |
Additional relevant MeSH terms:
Hydrocephalus Hydrocephalus, Normal Pressure Brain Diseases Central Nervous System Diseases Nervous System Diseases |