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Search / Trial NCT00221091

Study to Evaluate Efficacy of Shunt Operation for Idiopathic Normal Pressure Hydrocephalus

Launched by TRANSLATIONAL RESEARCH CENTER FOR MEDICAL INNOVATION, KOBE, HYOGO, JAPAN · Sep 13, 2005

Trial Information

Current as of May 20, 2025

Completed

Keywords

Idiopathic Normal Pressure Hydrocephalus Shunt

ClinConnect Summary

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 establi...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients who had at least one more points of the triad (gait disturbance, cognitive impairment, and urinary incontinence) in Japan NPH grading scale revised, and had disproportionate ventriculomegaly (Evans index \>0.3) with closing of the CSF space at high convexity on MRI. These patients must be diagnosed clinically other causative disorders, and ventricular dilatation due to disturbance of the cerebrospinal fluid (CSF) circulation. Be able to give informed consent.
  • Exclusion Criteria:
  • 1) Cannot have an MRI scan 2) Has a problem with bleeding tendency and other serological examination. (liver enzyme and renal dysfunction, blood coagulopathy, and etc.) 3) Is unable to understand the risks of the testing and surgical therapy. 4) is tolerable for one year follow up after shunting operation.

About Translational Research Center For Medical Innovation, Kobe, Hyogo, Japan

The Translational Research Center for Medical Innovation (TRI) in Kobe, Hyogo, Japan, is a pioneering institution dedicated to advancing medical research and innovation. Focused on bridging the gap between laboratory discoveries and clinical applications, TRI fosters a collaborative environment that brings together researchers, clinicians, and industry partners. By facilitating cutting-edge translational studies and clinical trials, TRI aims to accelerate the development of novel therapies and improve patient outcomes. With state-of-the-art facilities and a commitment to excellence, TRI is at the forefront of transforming medical science into tangible health solutions.

Locations

Nanao Shi, Ishikawa Pref., Japan

Patients applied

0 patients applied

Trial Officials

Masatsune Ishikawa, M.D.

Principal Investigator

Department of Neurosurgery, kitano Hospital, The Tazuke Kofukai Medical Research Institute. City: Osaka

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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