UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000045915 |
|---|---|
| Receipt number | R000052410 |
| Scientific Title | Human Augmentation by therapeutic stimulation of brain and peripherals |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2021/10/29 10:50:52 |
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Basic information
Public title
Human Augmentation by therapeutic stimulation of brain and peripherals
Acronym
Human Augmentation by therapeutic stimulation of brain and peripherals
Scientific Title
Human Augmentation by therapeutic stimulation of brain and peripherals
Scientific Title:Acronym
Human Augmentation by therapeutic stimulation of brain and peripherals
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate stimulation patterns to the human brain and peripherals affect human augmentation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electroencephalogram, electromyogram, center of pressure, eye tracking
Key secondary outcomes
Comparison before and after the intervention.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Perform therapeutic stimulation to the brain and peripherals.
Interventions/Control_2
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
| 32 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Tokyo University of Science faculty and students who obtained their consent to cooperate with this research.
2. Person who does not have pain during measurement or exercise.
3. Person who does not have history of lower-limb surgery.
4. Person who does not have history of cardiac or respiratory disease.
5. Person who does not have history of neurological disorder.
Key exclusion criteria
Those who do not satisfy the demands above.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | Yamamoto |
| Last name | Takemura |
Organization
Tokyo University of Science
Division name
Faculty of Science and Technology
Zip code
278-8510
Address
2641, Yamazaki, Noda, Chiba
TEL
0471241501
takemura@rs.tus.ac.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | Yamamoto |
| Last name | Yamamoto |
Organization
Tokyo University of Science
Division name
Faculty of Science and Technology
Zip code
278-8510
Address
2641, Yamazaki, Noda, Chiba
TEL
0471241501
Homepage URL
m-yamamoto@rs.tus.ac.jp
Sponsor or person
Institute
Tokyo University of Science
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Review Committee at Tokyo University of Science
Address
2641, Yamazaki, Noda, Chiba
Tel
0471241501
bio@admin.tus.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 | 04 | 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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | 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
| 2021 | Year | 10 | Month | 29 | Day |
Last modified on
| 2021 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052410
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