UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051291 |
|---|---|
| Receipt number | R000058484 |
| Scientific Title | Single Group Study on Blood Flow Variability with Low-Frequency Electrical Stimulation Devices |
| Date of disclosure of the study information | 2023/06/08 |
| Last modified on | 2023/06/08 10:02:21 |
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Basic information
Public title
Study on Blood Flow Variability with Low-Frequency Electrical Stimulation Devices
Acronym
Efficacy of Low-Frequency Electrical Stimulation Devices on Blood Flow Variation
Scientific Title
Single Group Study on Blood Flow Variability with Low-Frequency Electrical Stimulation Devices
Scientific Title:Acronym
Efficacy of Low-Frequency Electrical Stimulation Devices on Blood Flow Variation
Region
| Japan |
Condition
Condition
Lifestyle disease
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of low-frequency electrical stimulation on peripheral vascular blood flow in healthy subjects and to examine the preventive effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of peripheral vascular blood flow at the beginning and end of low-frequency electrical stimulation
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
21 minutes / 1 time
1 time/1 week, 4times
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adult volunteer
Key exclusion criteria
Persons who are unable to communicate during the interview
Persons with certain implantable electronic devices such as pacemakers
Persons with acute (painful) illness of unknown cause
Persons with heart problems
Persons with a high bleeding predisposition
Persons with malignant tumors
Pregnant and parturient women
Persons with febrile illness
Persons with contagious diseases
Persons at risk of vascular disorders such as thrombosis, venous thrombosis, varicose veins, etc.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | TAMURA |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Bioinformatics
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2554
yutaka_tamura@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | SUGANAMI |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Bioinformatics
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2564
Homepage URL
a.suganami@restaff.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Ethics Committee of Graduate School of Medicine, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-226-2462
inohana-rinri@chiba-u.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
| 2023 | Year | 06 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
7
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
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 06 | Month | 08 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058484
| 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 |
