ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus
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| ClinicalTrials.gov Identifier: NCT00946127 |
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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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Sponsor:
Johns Hopkins University
Information provided by (Responsible Party):
Daniele Rigamonti, Johns Hopkins University
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Brief 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Hydrocephalus | Procedure: Ventriculoperitoneal Shunt Placement Procedure: Endoscopic Third Ventriculostomy(ETV) |
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 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 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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Shunt Arm
Ventriculoperitoneal Shunt
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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. |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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 |
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.
Criteria
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
Information from the National Library of Medicine
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
Locations
| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
Sponsors and Collaborators
Johns Hopkins University
Investigators
| 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:
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Normal Pressure Hydrocephalus Communicating Hydrocephalus Gait disorder |
Cognition Shunt Endoscopic Third Ventriculostomy. |
Additional relevant MeSH terms:
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Hydrocephalus Hydrocephalus, Normal Pressure Brain Diseases Central Nervous System Diseases Nervous System Diseases |