UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049893 |
|---|---|
| Receipt number | R000056819 |
| Scientific Title | Research on optimized brain stimulation of tDCS for language function |
| Date of disclosure of the study information | 2022/12/25 |
| Last modified on | 2025/07/04 17:25:52 |
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Basic information
Public title
Research on optimized brain stimulation of tDCS for language function
Acronym
Research on optimized brain stimulation of tDCS for language function
Scientific Title
Research on optimized brain stimulation of tDCS for language function
Scientific Title:Acronym
Research on optimized brain stimulation of tDCS for language function
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop optimal tDCS conditions for improving each individual's language function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
picture naming task
semantic judgement task
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
Interventions/Control_2
transcranial direct current stimulation
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
right-handedness
healthy individuals
Key exclusion criteria
No metal or other implants in the body, no history of epilepsy or central nervous system disease, etc.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Natsue |
| Middle name | |
| Last name | Yoshimura |
Organization
Tokyo Institute of Technology
Division name
Institute of Innovative Research
Zip code
226-8503
Address
4259 Nagatsuta-cho, Midori-ku Yokohama, Kanagawa
TEL
050-3702-7046
yoshimura.n.ac@m.titech.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Gyoda |
Organization
Ghoonuts corporation
Division name
Research and development
Zip code
600-8813
Address
ASTEM building, Kyoto KRP, 134, Minami-machi, chudoji, shimokyo-ku, Kyoto
TEL
08090722461
Homepage URL
t-gyoda@ghoonuts.com
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Innovative Research
Address
2-12-1, Ookayama, Meguro-ku, Tokyo
Tel
03-5734-3808
hitorinri@jim.titech.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
| 2022 | Year | 12 | Month | 25 | 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
55
Results
The study demonstrated that brain regions exhibiting high activity during language tasks could be identified using EEG in a manner approximating fMRI. Furthermore, when anodal stimulation was applied to the regions identified by EEG, the reaction time in a naming task significantly improved compared to sham stimulation or stimulation of the Broca's area. These findings suggest the potential efficacy of optimized brain stimulation.
Results date posted
| 2024 | Year | 12 | Month | 26 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
This is because the paper is currently under peer review, and additional analyses may be required.
Date of the first journal publication of results
Baseline Characteristics
Fifty-five healthy adults aged 24 to 64 participated in the study. All participants were right-handed and had no history of neurological or psychiatric disorders.
Participant flow
Individuals who applied through research participant recruitment services on SNS platforms operated by research institutions or universities, or via Google Forms linked on their official websites, were screened for eligibility based on medical history and other criteria. Eligible individuals were then provided with an explanation of the study, and informed consent was obtained.
Adverse events
Pain or itching was observed during electrical stimulation, but these effects were temporary. Additionally, no differences in pain or itching were noted between the real stimulation and sham stimulation conditions.
Outcome measures
Naming Function
Semantic Judgment Function
Brain Regions of EEG Activity During Language Tasks
BOLD Activity in fMRI During Language Tasks
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 07 | 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
| 2022 | Year | 12 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056819
