Novel Parameters for the Prediction of Ventriculoperitoneal Shunting Efficacy in Patients With iNPH (iNPH)
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ClinicalTrials.gov Identifier: NCT02495610 |
Recruitment Status
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Recruiting
First Posted
: July 13, 2015
Last Update Posted
: November 1, 2017
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Tracking Information | |||||||||
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First Submitted Date ICMJE | June 23, 2015 | ||||||||
First Posted Date ICMJE | July 13, 2015 | ||||||||
Last Update Posted Date | November 1, 2017 | ||||||||
Study Start Date ICMJE | June 2015 | ||||||||
Estimated Primary Completion Date | July 2019 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Gait Analysis on treadmill by foot print plate and overground walking by time keeping [ Time Frame: 3 months ] 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)
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Original Primary Outcome Measures ICMJE |
Gait Analysis [ Time Frame: 3 months ] a composite of the following measurements: Step width, step lenght, Foot rotation, double stance phase, cadence, velocity (Timed 25 Foot Walj, endurance (6 minute walking test)
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Change History | Complete list of historical versions of study NCT02495610 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Novel Parameters for the Prediction of Ventriculoperitoneal Shunting Efficacy in Patients With iNPH | ||||||||
Official Title ICMJE | A Prospective Single-centre Trial Investigating Novel Parameters for the Prediction of Ventriculoperitoneal Shunting Efficacy in Patients With Idiopathic Normal Pressure Hydrocephalus | ||||||||
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. | ||||||||
Detailed Description | Idiopathic normal pressure hydrocephalus (iNPH) is an important differential diagnosis of dementia in the elderly patients. It is characterised by an enlargement of the ventricular system and can lead to cognitive deficits, gait disturbance and incontinence. Treatment consists of a ventriculoperitoneal shunt. A major challenge is the identification of patients who suffer from iNPH and who will benefit from shunt surgery. Typically, cerebrospinal fluid (CSF) is withdrawn by a spinal tap, and walking speed and steps per distance are measured before and thereafter. In patients who benefit from the test tap the diagnosis iNPH is made and the indication for shunt surgery is ascertained. The diagnostic procedure is not standardised. Little is known about the examinations and time-points suited best to predict surgery outcome. Thus, patients may undergo surgery who do not benefit, and patients who would benefit may be missed. This study aims at defining a diagnostic algorithm to improve the prediction of surgery outcome in patients supposed to suffer from iNPH. In 25 serial patients, motor function will be analysed in detail by functional tests and a treadmill-based analysis before and after the test tap at different time-points. In addition, neuropsychological tests and MRI investigations (DWI and pw) will be done, and patients will fill-out a micturition diary. Patients who do not respond to the test tap will be offered a lumbar drainage for continuous CSF release as diagnostic escalation with repeated tests thereafter. Patients who finally undergo shunt surgery will be re-assessed to identify those who responded to surgery. Thereby, post-hoc analyses will identify those parameter(s) that had the best predictive value for surgery outcome. To confirm the parameters derived from such exploratory analyses, these parameters will be validated in another series of 25 patients. The results of this study have the potential to improve the clinical routine and to provide a strategic advantage for the University Hospital Zurich. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Not Applicable | ||||||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Idiopathic Normal Pressure Hydrocephalus | ||||||||
Intervention ICMJE | Other: Gait analysis and MRI:
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Study Arms | Gait analysis and MRI
Intervention: Other: Gait analysis and MRI: |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
70 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date | August 2019 | ||||||||
Estimated Primary Completion Date | July 2019 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 50 Years to 85 Years (Adult, Senior) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Switzerland | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT02495610 | ||||||||
Other Study ID Numbers ICMJE | KEK-ZH-Nr. 2014-0423 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement | Not Provided | ||||||||
Responsible Party | University of Zurich | ||||||||
Study Sponsor ICMJE | University of Zurich | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | University of Zurich | ||||||||
Verification Date | October 2017 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |