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

Conditions

Idiopathic Normal Pressure Hydrocephalus

Keywords

idiopathic normal pressure hydrocephalus, shunt

Brief 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.

Detailed 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.

Madoka Nakajima, Shigeki Yamada, Masakazu Miyajima, Kaito Kawamura, Chihiro Akiba et al. (9 authors)

Frontiers in Neurology2021-11-0216 citations

10.3389/fneur.2021.769216

Cost-effectiveness analysis of shunt surgery for idiopathic normal pressure hydrocephalus based on the SINPHONI and SINPHONI-2 trials.

Kameda M, Yamada S, Atsuchi M, Kimura T, Kazui H, Miyajima M, Mori E, Ishikawa M, Date I, SINPHONI and SINPHONI-2 Investigators.

2017-03-0126 citations

10.1007/s00701-017-3115-2

The value of the cerebrospinal fluid tap test for predicting shunt effectiveness in idiopathic normal pressure hydrocephalus.

Ishikawa M, Hashimoto M, Mori E, Kuwana N, Kazui H.

2012-01-13100 citations

10.1186/2045-8118-9-1

Diagnosis of idiopathic normal pressure hydrocephalus is supported by MRI-based scheme: a prospective cohort study.

Hashimoto M, Ishikawa M, Mori E, Kuwana N, Study of INPH on neurological improvement (SINPHONI).

2010-10-31345 citations

10.1186/1743-8454-7-18

Interventions

PROCEDUREventriculo-peritoneal shunt

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to 85 Years

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame
modified Rankin scale	—

Secondary

Measure	Time frame
cognitive function, NPH grading scale	—

Countries

Japan

Outcome results

None listed