UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054011 |
|---|---|
| Receipt number | R000061665 |
| Scientific Title | Effects of alternating current stimulation on brain activity and motion control |
| Date of disclosure of the study information | 2024/03/29 |
| Last modified on | 2024/03/29 18:53:05 |
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Basic information
Public title
Effects of alternating current stimulation on brain activity and motion control
Acronym
Effects of alternating current stimulation on brain activity and motion control
Scientific Title
Effects of alternating current stimulation on brain activity and motion control
Scientific Title:Acronym
Effects of alternating current stimulation on brain activity and motion control
Region
| Japan |
Condition
Condition
Healthy participants and patients with brain disorders
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effects of alternating current stimulation on brain activity and motion control.
Basic objectives2
Others
Basic objectives -Others
Electroencephalographic oscillations
Body coordinates
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Electroencephalograms and body coordinates are recorded.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants are seated with their hands and forearms resting on their thighs. A battery-powered current stimulator delivers sinusoidal stimuli for 10 minutes (peak-to-peak 1-2 mA).
Interventions/Control_2
Participants are seated with their hands and forearms resting on their thighs. A battery-powered current stimulator delivers sham sinusoidal stimuli for 10 minutes (peak-to-peak 0 mA).
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 and Female
Key inclusion criteria
The participants are right-handed and have no risk of adverse events from transcranial alternating current stimulation or MRI scan.
Key exclusion criteria
None
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Kasei University
Division name
Faculty of Health Sciences
Zip code
350-1398
Address
2-15-1 Inariyama, Sayama City, Saitama
TEL
042-955-6074
suzuki-mak@tokyo-kasei.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Kasei University
Division name
Faculty of Health Sciences
Zip code
350-1398
Address
2-15-1 Inariyama, Sayama City, Saitama
TEL
042-955-6074
Homepage URL
suzuki-mak@tokyo-kasei.ac.jp
Sponsor or person
Institute
Tokyo Kasei University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Research ethics committee of the Tokyo Kasei University
Address
2-15-1 Inariyama, Sayama City, Saitama
Tel
042-952-1621
kanuma-y@tokyo-kasei.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 | 29 | 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
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2029 | 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 | 29 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061665
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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