UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021058 |
|---|---|
| Receipt number | R000024296 |
| Scientific Title | The effect of transcranial direct current stimulation (tDCS) on the neural network system: randomized double-blind crossover trials. |
| Date of disclosure of the study information | 2016/02/16 |
| Last modified on | 2022/02/21 12:16:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of transcranial direct current stimulation (tDCS) on the neural network 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 neural network 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 26 minutes) on the neural network system, cognitive functions and psychological functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
changes of the brain function with tDCS using magnetoencephalographic analysis of auditory steady state evoked responses
evaluation will be done immediately after tDCS
Key secondary outcomes
changes in cognitive/psychological function and complexity/graph metrics of magnetoencephalography
evaluation will be done immediately after tDCS
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, 26 minutes) -> (wash out) -> sham stimulation.
Interventions/Control_2
sham stimulation -> (wash out) -> Transcranial direct current stimulation(2mA, 26 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
24
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Takahashi |
Organization
Kanazawa University
Division name
Research Center for Child Mental Development
Zip code
920-0934
Address
13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2304
takahash-fki@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Takahashi |
Organization
Kanazawa University
Division name
Research Center for Child Mental Development
Zip code
920-0934
Address
13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2304
Homepage URL
takahash-fki@umin.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
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
Kanazawa University
Address
13-1 Takara-machi, Kanazawa, Ishikawa, Japan
Tel
076-265-2304
takahash@u-fukui.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
| 2016 | Year | 02 | Month | 16 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 09 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 09 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 09 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 16 | Day |
Last modified on
| 2022 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024296
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
