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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034998
Receipt No. 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 2018/11/26

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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
Middle name
Last name Motoaki Sugiura
Organization Tohoku University
Division name Institute of Development, Aging and Cancer
Zip code
Address 4-1, Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-8563
Email sugiura@tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Ishibashi
Organization Tohoku University
Division name Institute of Development, Aging and Cancer
Zip code
Address 4-1, Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-8563
Homepage URL
Email ryo.ishibashi.b2@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
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 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
2018 Year 12 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 11 Month 26 Day
Last modified on
2018 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039909

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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