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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019280
Receipt No. R000022191
Scientific Title The effect of transcranial direct current stimulation (tDCS) on the dopamine system :randomized double-blind crossover trials.
Date of disclosure of the study information 2015/10/20
Last modified on 2020/04/11

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Basic information
Public title The effect of transcranial direct current stimulation (tDCS) on the dopamine system :randomized double-blind crossover trials.
Acronym Transcranial direct current stimulation and brain function.
Scientific Title The effect of transcranial direct current stimulation (tDCS) on the dopamine system :randomized double-blind crossover trials.
Scientific Title:Acronym Transcranial direct current stimulation and brain function.
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 30 minutes) on the dopamine system and cognitive performance such as memory and spacial recognition.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Change of the dopamine transporter density after the transcranial direct current stimulation
Key secondary outcomes Choice reaction time, visual working memory, mental rotation task

Base
Study type Interventional

Study design
Basic design Cross-over
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 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Transcranial direct current stimulation(2mA,30 minutes) -> (wash out) -> sham stimulation.
Interventions/Control_2 sham stimulation -> (wash out) -> Transcranial direct current stimulation(2mA,30 minutes).
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

Not applicable
Gender Male
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 disability.
Key exclusion criteria People with the past history of the head injury accompanied by the consciousness disturbance 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.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Tetsu
Middle name
Last name Hirosawa
Organization Kanazawa University
Division name Neuropsychiatry
Zip code 9208641
Address 13-1 Takara-machi, Kanazawa 920-8641, Japan
TEL 076-265-2304
Email hirosawatetsu1982@yahoo.co.jp

Public contact
Name of contact person
1st name Tetsu
Middle name
Last name Hirosawa
Organization Kanazawa University
Division name Neuropsychiatry
Zip code 9208641
Address 13-1 Takara-machi, Kanazawa 920-8641, Japan
TEL 076-265-2304
Homepage URL
Email hirosawatetsu1982@yahoo.co.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 Certified Review Board, Kanazawa University
Address 13-1 Takara-machi, Kanazawa 920-8641, Japan
Tel 0762652048
Email hpsangak@adm.kanazawa-u.ac.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 10 Month 20 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 Open public recruiting
Date of protocol fixation
2015 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 20 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
2015 Year 10 Month 08 Day
Last modified on
2020 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022191

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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