UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019963
Receipt number R000023049
Scientific Title Evaluation of brain functional connectivity using resting state fMRI in idiopathic normal pressure hydrocephalus patients after lumboperitoneal shunt.
Date of disclosure of the study information 2015/11/30
Last modified on 2020/06/02 10:50:11

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Basic information

Public title

Evaluation of brain functional connectivity using resting state fMRI in idiopathic normal pressure hydrocephalus patients after lumboperitoneal shunt.

Acronym

Evaluation of brain functional connectivity in idiopathic normal pressure hydrocephalus patients after lumboperitoneal shunt.

Scientific Title

Evaluation of brain functional connectivity using resting state fMRI in idiopathic normal pressure hydrocephalus patients after lumboperitoneal shunt.

Scientific Title:Acronym

Evaluation of brain functional connectivity in idiopathic normal pressure hydrocephalus patients after lumboperitoneal shunt.

Region

Japan


Condition

Condition

idiopathic normal pressure hydrocephalus

Classification by specialty

Neurosurgery Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the functional MRI before and after shunt surgery in idiopathic hydrocephalus. We will bring out the change of default mode network, salience network and executive control network before and after surgery.

Basic objectives2

Others

Basic objectives -Others

To evaluate the change of fMRI after improvement of cognitive function.

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

We will evaluate functional MRI and motor and cognitive function before and 2 months after surgery.
cognitive function(ACE-3, MMSE, FAB, WAIS-R, ADAS, WMS-R, TMT), motor function( Timed Up&Go test), functional MRI

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Functional MRI will be performed before and 2months after surgery.

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

60 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with idiopathic normal pressure hydrocephalus. Patients with good enough cognitive function for the agreement of this study.

Key exclusion criteria

Untolerable for MRI study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Kazuhito
Middle name
Last name Takeuchi

Organization

Nagoya University

Division name

Department of Neurosurgery

Zip code

466-8550

Address

65 tsurumai, syowa-ku, nagoya, Aichi

TEL

052-744-2353

Email

mail@wajit.com


Public contact

Name of contact person

1st name Kazuhito
Middle name
Last name Takeuchi

Organization

Nagoya University

Division name

Department of Neurosurgery

Zip code

466-8550

Address

65 tsurumai, syowa-ku, nagoya, Aichi

TEL

052-744-2353

Homepage URL


Email

mail@wajit.com


Sponsor or person

Institute

Department of Neurosurgery, Nagoya University

Institute

Department

Personal name



Funding Source

Organization

Department of Neurosurgery, Nagoya University

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

Nagoya University

Address

65 tsurumai, Showa, Nagoya, Aichi

Tel

052-744-2360

Email

ktakeuchi@med.nagoya-u.ac.jp


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

名古屋大学病院


Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 30 Day


Related information

URL releasing protocol

2018/4/1

Publication of results

Unpublished


Result

URL related to results and publications

2018/4/1

Number of participants that the trial has enrolled

6

Results

It was discontinued due to the difficulty of accumulating the number of cases and the difficulty of maintaining and sustaining the test.

Results date posted

2020 Year 06 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

It was cancelled because of the difficulty in securing the number of patients with normal pressure hydrocephalus.

Participant flow

Discontinuation

Adverse events

None

Outcome measures

The number of cases that could be analyzed was not reached.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2015 Year 05 Month 27 Day

Date of IRB

2015 Year 05 Month 27 Day

Anticipated trial start date

2015 Year 05 Month 27 Day

Last follow-up date

2018 Year 04 Month 01 Day

Date of closure to data entry

2018 Year 04 Month 01 Day

Date trial data considered complete

2018 Year 04 Month 01 Day

Date analysis concluded

2018 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2015 Year 11 Month 27 Day

Last modified on

2020 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023049


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name