UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024826 |
|---|---|
| Receipt number | R000028575 |
| Scientific Title | Central mechanism of sensorimotor functions in the orofacial area: Approaches using brain stimulation and brain imaging |
| Date of disclosure of the study information | 2016/11/14 |
| Last modified on | 2017/05/20 23:19:55 |
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Basic information
Public title
Central mechanism of sensorimotor functions in the orofacial area: Approaches using brain stimulation and brain imaging
Acronym
Central mechanism of oral functions
Scientific Title
Central mechanism of sensorimotor functions in the orofacial area: Approaches using brain stimulation and brain imaging
Scientific Title:Acronym
Central mechanism of oral functions
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the central mechanism of sensorimotor functions in the orofacial area using noninvasive brain stimulation and brain imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Latency and magnitude of motor evoked potentials
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
noninvasive brain stimulation(one time within 10 min)
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Health history without neuropsychiatric abnormality
Key exclusion criteria
Unsuitable for the clinical study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoko Koganemaru |
Organization
Kyoto University Graduate School of Medicine
Division name
Human brain research center
Zip code
Address
Shogoin Kawahara-cho54, Sakyo-ku, Kyoto
TEL
075-751-3695
satokogane@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Maezawa |
Organization
Graduate School of Dental Medicine Hokkaido University
Division name
Oral Physiology
Zip code
Address
Kita 13 nishi 7, Kita-ku, Sapporo
TEL
011-706-4229
Homepage URL
maezawa@den.hokudai.ac.jp
Sponsor or person
Institute
japan science and technology agency
Institute
Department
Personal name
Funding Source
Organization
japan science and technology agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 11 | Month | 14 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 14 | 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
| 2016 | Year | 11 | Month | 14 | Day |
Last modified on
| 2017 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028575
