UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034077 |
|---|---|
| Receipt number | R000038474 |
| Scientific Title | Investigation of stress response system in the brain by transcranial magnetic stimulation |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2018/09/10 14:47:07 |
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Basic information
Public title
Investigation of stress response system in the brain by transcranial magnetic stimulation
Acronym
Investigation of stress response system in the brain by transcranial magnetic stimulation
Scientific Title
Investigation of stress response system in the brain by transcranial magnetic stimulation
Scientific Title:Acronym
Investigation of stress response system in the brain by transcranial magnetic stimulation
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the stress response mechanism in the brain using transcranial magnetic stimulation
Basic objectives2
Others
Basic objectives -Others
Exploring of the stress response system in the brain
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of adrenocorticotropic hormone and functional brain connectivity by brain stimulation
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
Transcranial magnetic stimulation
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy subjects
Key exclusion criteria
Subjects with mental / nervous / physical disorders, those with magnetic metal embedded in the body, users of implants, those with a tendency for claustrophobic illness, epilepsy, family history of convulsive attacks
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiko Kano |
Organization
Frontier Research Institute for Interdisciplinary Science
Division name
Creative interdisciplinary research division
Zip code
Address
2-1 Seiryo, Aoba, Sendai, Japan
TEL
+81(0)22-717-8218
mkano@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiko Kano |
Organization
Frontier Research Institute for Interdisciplinary Science
Division name
Creative interdisciplinary research division
Zip code
Address
2-1 Seiryo, Aoba, Sendai, Japan
TEL
+81(0)22-717-8218
Homepage URL
mkano@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Frontier Research Institute for Interdisciplinary Science
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 | 10 | 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 | 09 | Month | 18 | 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 | 09 | Month | 10 | Day |
Last modified on
| 2018 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038474
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
