Clinical Trials Logo

Clinical Trial Summary

This study evaluates the efficacy of shunt operation for idiopathic normal pressure hydrocephalus, and determines the diagnostic value of noninvasive procedures commonly practiced in the clinic.


Clinical Trial Description

Idiopathic normal pressure hydrocephalus (iNPH) is a syndrome characterized by ventricular dilatation due to disturbed cerebrospinal fluid (CSF) circulation, accompanied by gait disturbance, dementia and/or urinary incontinence without causative disorders. With the aging of Japanese society, the number of patients is increasing, requiring diagnostic and therapeutic guidelines for the improvement of the patients' quality of life and social care. Under such conditions, this project was made as the prospective study of iNPH on Neurological Improvement (SINPHONI ). This study aims 1) to establish methods for non-invasive diagnosis of iNPH, and 2) to demonstrate therapeutic outcome of shunting operation by Codman Hakim programmable valve (CHPV). In this protocol, the evaluation of validity on MRI, tap test, CT cisternography, and CBF (3D-SSP) will be done in the diagnosis, and manual of initial setting pressure in CHPV for prevention of overdrainage problems will be estimated by modified Rankin scale (as primary endpoint) and some another scales during 1 year. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00221091
Study type Interventional
Source Translational Research Informatics Center, Kobe, Hyogo, Japan
Contact
Status Completed
Phase Phase 2
Start date September 2004
Completion date October 2005

See also
  Status Clinical Trial Phase
Completed NCT01570257 - A Trial of High and Low Pressure Level Settings on a Programmable Ventriculoperitoneal Shunt Valve for Idiopathic Normal Pressure Hydrocephalus N/A
Recruiting NCT04998175 - Multi-omics Research of Idopathic Normal Pressure Hydrocephalus (iNPH) N/A
Recruiting NCT06428734 - Clinical Outcome in Patients With INPH
Completed NCT01319136 - Improved Analysis Methods for Infusion Tests N/A
Active, not recruiting NCT04795089 - Gait Pattern and Experienced Global Change After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus
Active, not recruiting NCT02495610 - Novel Parameters for the Prediction of Ventriculoperitoneal Shunting Efficacy in Patients With iNPH N/A
Completed NCT01374048 - Intracranial Pressure Waves Via Lumbar Puncture N/A