Novel Parameters for the Prediction of Ventriculoperitoneal Shunting Efficacy in Patients With iNPH

NCT02495610 | Completed

• 1 other identifier: KEK-ZH-Nr. 2014-0423
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

INPH is a chronic, progressive disease characterised by enlarged ventricles in the absence of elevated intracranial pressure. Patients often present with the Hakim triad comprising gait disturbance, dementia and urinary incontinence. Treatment consists of ventriculoperitoneal (VP) shunting reducing the cerebrospinal fluid (CSF) volume in the central nervous system (CNS); a generally safe and well tolerated procedure nevertheless invasive in nature and associated with surgical risk. The currently used diagnostic algorithms to predict surgery outcome by testing patients before and after a diagnostic spinal tap temporarily reducing the CSF volume in the CNS are of wide variability and limited validity. Developing measures to accurately diagnose and select patients for intervention is thus of great importance. The objective of this study is to define and validate a diagnostic algorithm for the selection of patients with symptoms compatible with iNPH for shunt surgery.

Conditions

Idiopathic Normal Pressure Hydrocephalus

Keywords

NPH; Gait analysis; neuropsychology; micturition diary; MRI

Outcome Measures

Primary Outcomes (1)

• Gait Analysis on treadmill by foot print plate and overground walking by time keeping

  a composite of the following measurements: Step width, step length, Foot rotation, double stance phase, cadence, velocity (Timed 25 Foot Walk, endurance (6 minute walking test)

  3 months

Secondary Outcomes (3)

• MRI

  3 months

• Urological function by micturition diary

  3 months

• Neuropsychology by validated testing

  3 months

Study Arms (1)

Gait analysis and MRI

OTHER

* Gait analysis: Intervention: Treadmill with pressure sensors (FDM-THM-M-System (Force distribution method-treadmill); 'Zebris' medical GmbH), study-specific, but routine procedures. * MRI: Intervention: Performed in a scanner at the University Hospital with standard MRI compatibility procedures; study specific is only the additional MRI after the CSF release with spinal tap or drainage.

Other: Gait analysis and MRI:

Interventions

Gait analysis and MRI: OTHER

* Gait analysis: Treadmill with pressure sensors (FDM-THM-M-System; 'Zebris' medical GmbH), study-specific, but routine procedures. * MRI: Performed in a scanner at the University Hospital with standard MRI compatibility procedures; study specific is only the additional MRI after the CSF release with spinal tap or drainage.

Gait analysis and MRI

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent.
• Age 50 years or above
• Impaired walking function for at least 3 months, onset at/ after 40 years of age.
• MRI or CT with enlarged ventricular system (Evans' index ≥0.30) without evidence of moderate or severe cortical atrophy.
• Eligible for shunt surgery.
• Eligible for analysis of gait, neuropsychological and urological function.
• Subjects must be able to understand the patient information sheet and comply with the requirements of the protocol.

You may not qualify if:

• Previous intracranial disorder or surgery.
• Contraindications to surgery or MRI
• Contraindications to the testing of gait, bladder or neuropsychological function.
• Presence of concomitant disease which might reasonably account for the clinical symptoms or radiological findings.
• Worsening of walking function secondary to any other condition occurring during the study.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (4)

• Hakim S, Adams RD. The special clinical problem of symptomatic hydrocephalus with normal cerebrospinal fluid pressure. Observations on cerebrospinal fluid hydrodynamics. J Neurol Sci. 1965 Jul-Aug;2(4):307-27. doi: 10.1016/0022-510x(65)90016-x. No abstract available.

  PMID: 5889177 BACKGROUND

• Marmarou A, Young HF, Aygok GA, Sawauchi S, Tsuji O, Yamamoto T, Dunbar J. Diagnosis and management of idiopathic normal-pressure hydrocephalus: a prospective study in 151 patients. J Neurosurg. 2005 Jun;102(6):987-97. doi: 10.3171/jns.2005.102.6.0987.

  PMID: 16028756 BACKGROUND

• Relkin N, Marmarou A, Klinge P, Bergsneider M, Black PM. Diagnosing idiopathic normal-pressure hydrocephalus. Neurosurgery. 2005 Sep;57(3 Suppl):S4-16; discussion ii-v. doi: 10.1227/01.neu.0000168185.29659.c5.

  PMID: 16160425 BACKGROUND

• Stolze H, Kuhtz-Buschbeck JP, Drucke H, Johnk K, Diercks C, Palmie S, Mehdorn HM, Illert M, Deuschl G. Gait analysis in idiopathic normal pressure hydrocephalus--which parameters respond to the CSF tap test? Clin Neurophysiol. 2000 Sep;111(9):1678-86. doi: 10.1016/s1388-2457(00)00362-x.

  PMID: 10964082 BACKGROUND

MeSH Terms

Interventions

Gait Analysis; Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Michael Weller, Prof.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: July 13, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CH (1)