ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus

This study has been terminated.
(Unable to recruit patients and lack of efficacy in ETV arm)
Sponsor:
Information provided by (Responsible Party):
Daniele Rigamonti, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00946127
First received: July 23, 2009
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Hydrocephalus
Procedure: Ventriculoperitoneal Shunt Placement
Procedure: Endoscopic Third Ventriculostomy(ETV)
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endoscopic Third Ventriculostomy (ETV) Versus Ventriculoperitoneal Shunting (VPS) for the Surgical Management of Normal Pressure Hydrocephalus

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

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 ] [ Designated as safety issue: Yes ]
  • Safety [ Time Frame: 0 through 12 months from Surgery ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: March 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • 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
  • Medtronic PS Strata Medical Valve--manufacturer-Medtronic Neurosurgery Inc
ETV arm
Endoscopic Third Ventriculostomy
Procedure: Endoscopic Third Ventriculostomy(ETV)
Patients who choose to undergo ETV arm would undergo a ventriculostomy at the start of study.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Daniele Rigamonti, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00946127     History of Changes
Other Study ID Numbers: NA_00014030
Study First Received: July 23, 2009
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Intracranial Hypertension

ClinicalTrials.gov processed this record on September 22, 2014