UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034998 |
|---|---|
| Receipt number | R000039909 |
| Scientific Title | Study on neural representation of tool concepts using transcranial direct current stimulation and functional magnetic resonance imaging |
| Date of disclosure of the study information | 2018/11/27 |
| Last modified on | 2023/05/31 12:14:31 |
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Basic information
Public title
Study on neural representation of tool concepts using transcranial direct current stimulation and functional magnetic resonance imaging
Acronym
Tool concept tdcs-fmri
Scientific Title
Study on neural representation of tool concepts using transcranial direct current stimulation and functional magnetic resonance imaging
Scientific Title:Acronym
Tool concept tdcs-fmri
Region
| Japan |
Condition
Condition
healthy young adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify how tDCS improves brain function for recognizing common tools. Mechanisms of improved brain processing for tools will be studied using functional magnetic resonance imaging (fMRI).
Basic objectives2
Others
Basic objectives -Others
Analysis on individual differences of tDCS effect and associated variance in brain activity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
brain activity during task execution measured with fucntional 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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We carry out a non-invasive neurostimulation (transcranial Direct Current Stimulation; tDCS) putting sponge electrodes on participants' scalp.
Our procedure abide by the official safety guideline provided by Nihonv Rinsho Seiri Gakkai (Japanese society of clinical physiology, 2011). We use NeuroConn DC-Stimulator-Plus. The anodal electrode will be located on FT7 or CP3 (as in international EEG10-20). Reference electrode will be located at around Fp2.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
having normal or corrected-to-normal vision.
having communication skill in Japanese enough for participating the experiment.
Key exclusion criteria
History of psychiatric/mental illnesses.
Currently taking any substances that can affect functions of the nervous system.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Motoaki |
| Middle name | |
| Last name | Sugiura |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer
Zip code
9808575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-8563
sugiura@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Ishibashi |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer
Zip code
9808575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-8563
Homepage URL
ryo.ishibashi.b2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
MEXT, Japan
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
School of Medicine, Tohoku University
Address
2-1, Seiryo-machi, Aoba-ku, Sendai-shi. 980-8575
Tel
not available
not available
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 | 11 | Month | 27 | 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 | 14 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 26 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039909
| Research Plan | |
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| 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 |
