UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013141
Receipt number R000015285
Scientific Title evaluation of cerebral function and hemodynamics using the near-infrared spectroscopy to the patient of normal pressure hydrocephalus
Date of disclosure of the study information 2014/02/12
Last modified on 2014/02/12 14:00:28

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Basic information

Public title

evaluation of cerebral function and hemodynamics using the near-infrared spectroscopy to the patient of normal pressure hydrocephalus

Acronym

NIRS study of cerebral function and hemodynamics in NPH patients

Scientific Title

evaluation of cerebral function and hemodynamics using the near-infrared spectroscopy to the patient of normal pressure hydrocephalus

Scientific Title:Acronym

NIRS study of cerebral function and hemodynamics in NPH patients

Region

Japan


Condition

Condition

Normal pressure hydrocephalus

Classification by specialty

Neurology Psychiatry Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to elucidate whether the functional and hemodynamic examination at frontal lobe using NIRS is useful for diagnosis of NPH.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of the parameters detectable by NIRS relevant to the frontal lobe function and hemodynamics before and after tap test

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Change of frontal lobe function is evaluated by NIRS before and after tap test and shunt operation. In addition, change of the cerebral hemodynamics during tap test is observed by NIRS.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who are suspected normal pressure hydrocephalus by clinical symptoms or head CT/MRI

Key exclusion criteria

Patients who cannot take NIRS examination since cognitive dysfunction is remarkable

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shin-Ichi Miyatake

Organization

Osaka Medical College

Division name

department of Neurosurgery

Zip code


Address

2-7, Daigakumachi, Takatsuki-shi, Osaka

TEL

072-683-1221

Email

neu070@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshinaga Kajimoto

Organization

Osaka Medical College

Division name

department of Neurosurgery

Zip code


Address

2-7, Daigakumachi, Takatsuki-shi, Osaka

TEL

072-683-1221

Homepage URL


Email

neu039@poh.osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical College

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 12 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2014 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 12 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 02 Month 12 Day

Last modified on

2014 Year 02 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015285


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name