MedDataX Logo

ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus

NCT ID: NCT00946127

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hydrocephalus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Normal Pressure Hydrocephalus Communicating Hydrocephalus Gait disorder Cognition Shunt Endoscopic Third Ventriculostomy.

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Shunt Arm

Ventriculoperitoneal Shunt

Ventriculoperitoneal Shunt Placement

Intervention Type PROCEDURE

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.

ETV arm

Endoscopic Third Ventriculostomy

Endoscopic Third Ventriculostomy(ETV)

Intervention Type PROCEDURE

Patients who choose to undergo ETV arm would undergo a ventriculostomy at the start of study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Endoscopic Third Ventriculostomy(ETV)

Patients who choose to undergo ETV arm would undergo a ventriculostomy at the start of study.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniele Rigamonti

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniele Rigamonti, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15214981 (View on PubMed)

Gangemi 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.

Reference Type BACKGROUND
PMID: 18728569 (View on PubMed)

Pujari 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.

Reference Type BACKGROUND
PMID: 18356257 (View on PubMed)

Dusick 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.

Reference Type BACKGROUND
PMID: 18054606 (View on PubMed)

Longatti 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.

Reference Type BACKGROUND
PMID: 15674750 (View on PubMed)

McGirt 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.

Reference Type BACKGROUND
PMID: 16239882 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NA_00014030

Identifier Type: -

Identifier Source: org_study_id