UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033099
Receipt number R000037729
Scientific Title Comparative study of solidity perception obtained by chewing and touch.
Date of disclosure of the study information 2018/07/01
Last modified on 2018/06/22 11:48:58

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Basic information

Public title

Comparative study of solidity perception obtained by chewing and touch.

Acronym

Study of solidity perception by chewing.

Scientific Title

Comparative study of solidity perception obtained by chewing and touch.

Scientific Title:Acronym

Study of solidity perception by chewing.

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the property and cortical mechanisms underlying solidity perception by chewing in comparison with that by touch.

Basic objectives2

Others

Basic objectives -Others

None

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Behavioral data
2. Data of cortical activity during behavioral tests obtained by functional MRI technique.

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

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Functional brain imaging experiment (fMRI)

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

35 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy right-handed adults

Key exclusion criteria

We will exclude all those who have:
*previous and present neurological and mental diseases,
*disorders in mastication and occlusion,
*abnormalities of sensation in the mouth and hands,
*visual disorder,
*pace maker, any orthopedic metals, and orthodontic wires in the body,
*any unmovable metallic accessories and body paints made of metallic pigments in the body
from participants of this study.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Narumi Katsuyama

Organization

Graduate School of Medical and Dental Sciences,
Tokyo Medical and Dental University

Division name

Department of Cognitive Neurobiology

Zip code


Address

1-5-45 Yushima, Bunkyo, Tokyo, Japan

TEL

81-3-5803-5445

Email

katz.cnb@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Narumi Katsuyama

Organization

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

Division name

Department of Cognitive Neurobiology

Zip code


Address

1-5-45 Yushima, Bunkyo, Tokyo, Japan

TEL

81-3-5803-5445

Homepage URL


Email

katz.cnb@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Nihon 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


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

2018 Year 07 Month 01 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

2018 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 10 Month 01 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

2018 Year 06 Month 22 Day

Last modified on

2018 Year 06 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037729


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name