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
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
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
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
