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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018310
Receipt No. R000017418
Scientific Title The effect of transcranial direct current stimulation (tDCS) on the cognitive performance in normal adults:double blind placebo control study.
Date of disclosure of the study information 2015/07/14
Last modified on 2020/02/16

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Basic information
Public title The effect of transcranial direct current stimulation (tDCS) on the cognitive performance in normal adults:double blind placebo control study.
Acronym Transcranial direct current stimulation and cognitive performance.
Scientific Title The effect of transcranial direct current stimulation (tDCS) on the cognitive performance in normal adults:double blind placebo control study.
Scientific Title:Acronym Transcranial direct current stimulation and cognitive performance.
Region
Japan

Condition
Condition Normal adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the effect of transcranial direct current stimulation (2mA on the head for 20 minutes) on the cognitive performance such as memory and spacial recognition of body parts.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Choice reaction time, visual working memory, mental rotation task
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Transcranial direct current stimulation(2mA,20 minutes).
Effective stimulation.
Anode on the posterior area.
Interventions/Control_2 Transcranial direct current stimulation(2mA,20 minutes).
Placebo stimulation.
Anode on the frontal area.
Interventions/Control_3 Sham stimulation.
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

Not applicable
Gender Male and Female
Key inclusion criteria Person without history of the mental disease.
Twenty years or older person at the time of the agreement acquisition.
Person without an intellectual obstacle.
Key exclusion criteria People with the past history of the head injury accompanied by the consciousness for 5 minutes or more.

People who have the past history of an organic disease in a brain.

People with the present or past history of substance dependence, loss of consciousness or convulsion.

People with a chronic headache.

A woman under pregnancy or with the possibility of pregnancy.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Mitsuru
Middle name
Last name Kikuchi
Organization Kanazawa University
Division name Research Center for Child Mental Development
Zip code 920-8640
Address 13-1 Takara-machi, Kanazawa 920-8641, Japan
TEL 076-265-2304
Email mitsuruk@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Mitsuru
Middle name
Last name Kikuchi
Organization Kanazawa University
Division name Research Center for Child Mental Development
Zip code 920-8640
Address 13-1 Takara-machi, Kanazawa 920-8641, Japan
TEL 076-265-2304
Homepage URL
Email mitsuruk@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization the Center of Innovation Program from Japan Science and Technology Agency, JST.
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 Innovative Clinical Research Center, Kanazawa University
Address 13-1 Takaramachi Kanazawa City
Tel 076-265-2049
Email crc.irb-knz@esct.jp

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
2015 Year 07 Month 14 Day

Related information
URL releasing protocol https://www.frontiersin.org/articles/10.3389/fnhum.2017.00181/full
Publication of results Published

Result
URL related to results and publications https://www.frontiersin.org/articles/10.3389/fnhum.2017.00181/full
Number of participants that the trial has enrolled 40
Results
Regarding the accuracy rate, a Wilcoxon rank-sum test (one-sided) revealed a significantly higher performance (i.e., higher accuracy rate) in the working memory with hand mental rotation (RWM) task in the right occipital anodal stimulation group (i.e., active condition, n = 20) than in the control group (W = 135.5, p-value = 0.020), which supported our hypothesis.
Results date posted
2020 Year 02 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Normal adult subjects
Participant flow
Public recruitment
Adverse events
no adverse event
Outcome measures
working memory with hand mental rotation 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 10 Month 01 Day
Date of IRB
2014 Year 10 Month 23 Day
Anticipated trial start date
2015 Year 07 Month 14 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 14 Day
Last modified on
2020 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017418

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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