ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus

NCT00946127 | Terminated

• 1 other identifier: NA_00014030
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Efficacy: Cognitive outcomes using RAVLT scale. Gait Outcomes evaluated based on Tinneti Gait and Balance Test. Functional Independence evaluated using Barthel index.

  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

  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.

  1 months, 3 months, 6 months and 1 year

Study Arms (2)

Shunt Arm

Ventriculoperitoneal Shunt

Procedure: Ventriculoperitoneal Shunt Placement

ETV arm

Endoscopic Third Ventriculostomy

Procedure: Endoscopic Third Ventriculostomy(ETV)

Interventions

Ventriculoperitoneal Shunt Placement 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.

Also known as: 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

Shunt Arm

Endoscopic Third Ventriculostomy(ETV) PROCEDURE

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

ETV arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (6)

• 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.

  PMID: 15214981 BACKGROUND

• 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.

  PMID: 18728569 BACKGROUND

• 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.

  PMID: 18356257 BACKGROUND

• 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.

  PMID: 18054606 BACKGROUND

• 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.

  PMID: 15674750 BACKGROUND

• 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.

  PMID: 16239882 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus; Hydrocephalus, Normal Pressure; Mobility Limitation

Interventions

Ventriculoperitoneal Shunt; Ventriculostomy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cerebrospinal Fluid Shunts; Anastomosis, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Daniele Rigamonti, MD, FACS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 24, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 3, 2012

Record last verified: 2012-10

Locations

US (1)