UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053806 |
|---|---|
| Receipt number | R000061412 |
| Scientific Title | Effects of transcranial direct current stimulation (tDCS) with different current direction on cortical excitability and motor performance. |
| Date of disclosure of the study information | 2024/03/12 |
| Last modified on | 2024/03/08 12:36:36 |
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Basic information
Public title
Effects of transcranial direct current stimulation (tDCS) with different current direction on brain activity and motor performance.
Acronym
Effects of transcranial direct current stimulation (tDCS) with different current direction.
Scientific Title
Effects of transcranial direct current stimulation (tDCS) with different current direction on cortical excitability and motor performance.
Scientific Title:Acronym
Effects of transcranial direct current stimulation (tDCS) with different current direction.
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study is to investigate the effects of transcranial direct current stimulation (tDCS) with different current direction on cortical excitability and motor performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Motor evoked potentials (MEPs), Pinch-tracking task
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The anterior-posterior current flow tDCS for 10 min
Interventions/Control_2
The posterior-anterior current flow tDCS for 10 min
Interventions/Control_3
The transverse current flow tDCS for 10 min
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
1.History of neurological, orthopedic or internal diseases that affect a performance task
2.Pacemaker or other metal objects in the body
3.History or family history of epileptic seizures
4.Take medication that affects the central nervous system
5.Any adverse reactions to electrical stimulation in the past
6.History or current history of psychiatric illness
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomofumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Juntendo university
Division name
Faculty of Health Science, Department of Physical Therapy
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3812-1780
t.yamaguchi.ja@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Mizuki |
| Middle name | |
| Last name | Hamasuna |
Organization
Juntendo university
Division name
Graduate School of Health Science, Master Course of Physical Therapy
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3812-1780
Homepage URL
fhs8323015@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Health Science, Juntendo University
Address
2-1-1 Hongo, Bunkyo-ku
Tel
03-3812-1780
fhs8323015@juntendo.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
| 2024 | Year | 03 | Month | 12 | 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
| 2023 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 08 | Day |
Last modified on
| 2024 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061412
| Research Plan | |
|---|---|
| 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 |
