UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059934 |
|---|---|
| Receipt number | R000068548 |
| Scientific Title | Effects of transcranial electrical stimulation based on individual EEG characteristics on visuospatial attention |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/12/01 19:15:25 |
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Basic information
Public title
Effects of transcranial electrical stimulation based on individual EEG characteristics on visuospatial attention
Acronym
Effects of transcranial electrical stimulation based on individual EEG characteristics on visuospatial attention
Scientific Title
Effects of transcranial electrical stimulation based on individual EEG characteristics on visuospatial attention
Scientific Title:Acronym
Effects of transcranial electrical stimulation based on individual EEG characteristics on visuospatial attention
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We generate stimulation waveforms based on individual EEG characteristics, both with and without removal of the 1/f component, and evaluate their effects on visuospatial attention. If the 1/f component plays a functional role, differential effects are expected to emerge between the two stimulation conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Accuracy rate on visuospatial attention tasks during stimulation
Key secondary outcomes
Response time for visuospatial attention tasks during stimulation.
Alpha power before and after intervention.
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
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Transcranial electrical stimulation based on individual characteristics of EEG
Interventions/Control_2
Stimulation with the removal of the aperiodic components from the individual power spectrum.
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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Participants who agree to participate in this study
Key exclusion criteria
Participants with a history of neurological or psychiatric disorders
Participants with implanted metal devices
Pregnant women
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | UEHATA ASATO |
| Middle name | |
| Last name | UEHATA |
Organization
Fukuoka International University of Health and Welfare, Graduate School
Division name
Graduate School of Health and Medical Sciences
Zip code
814-0001
Address
3-6-40 Momochihama, Sawara-ku, Fukuoka-shi, Fukuoka, Japan
TEL
092-832-1200
asa10assome@docomo.ne.jp
Public contact
Name of contact person
| 1st name | UEHATA ASATO |
| Middle name | |
| Last name | UEHATA |
Organization
Fukuoka International University of Health and Welfare, Graduate School
Division name
Graduate School of Health and Medical Sciences
Zip code
814-0001
Address
3-6-40 Momochihama, Sawara-ku, Fukuoka-shi, Fukuoka, Japan
TEL
092-832-1200
Homepage URL
asa10assome@docomo.ne.jp
Sponsor or person
Institute
Fukuoka International University of Health and Welfare, Graduate School
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka International University of Health and Welfare, Graduate School
Address
3-6-40 Momochihama, Sawara-ku, Fukuoka-shi, Fukuoka, Japan
Tel
092-832-1200
kyushu-nyushi@iuhw.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
福岡国際医療福祉大学大学院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 01 | 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
| 2025 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 12 | Month | 01 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068548
