UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042652 |
|---|---|
| Receipt number | R000048671 |
| Scientific Title | Elucidation of the frequency band of neuromuscular electrical stimulation that contributes to the increase in blood brain-derived neurotrophic factor |
| Date of disclosure of the study information | 2020/12/04 |
| Last modified on | 2024/02/26 12:20:23 |
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Basic information
Public title
Elucidation of the frequency band of neuromuscular electrical stimulation that contributes to the increase in blood brain-derived neurotrophic factor
Acronym
Research of EMS on BDNF
Scientific Title
Elucidation of the frequency band of neuromuscular electrical stimulation that contributes to the increase in blood brain-derived neurotrophic factor
Scientific Title:Acronym
Research of EMS on BDNF
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the frequency band of neuromuscular electrical stimulation (EMS) that contributes to the increase in blood brain-derived neurotrophic factor (BDNF) concentration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood BDNF concentration
Key secondary outcomes
Blood CPK concentration, motor unit behavior, cognitive function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
4 Hz of EMS, 30min/day, 3day/week for 8 weeks
Interventions/Control_2
20 Hz of EMS, 30min/day, 3day/week for 8 weeks
Interventions/Control_3
50 Hz of EMS, 30min/day, 3day/week for 8 weeks
Interventions/Control_4
placebo: no intervention
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who can participate in the intervention 3 days a week, 8 weeks
Key exclusion criteria
1. Those who go to the hospital for some illness
2. Systolic blood pressure prior to intervention is 140 mmHg or higher
3. Those with brain evolution or illness or dementia
4. Those with an embedded pacemaker
5. Those who plan to do vigorous exercise (such as a full marathon) during the research period
6. Those who are planning to start a new exercise
7. Those with skin hypersensitivity
8. Those with alcohol hypersensitivity
9. Those who are pregnant or may become pregnant
10. Students related to the laboratory of the principal investigator and the research coordinator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Nishikawa |
Organization
Kanazawa University
Division name
Faculty of Frontier Engineering, Institute of Science & Engineering
Zip code
920-1192
Address
Kakuma-machi, Kanazawa-shi, Ishikawa
TEL
076-234-4760
yuichi@se.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Nishikawa |
Organization
Kanazawa University
Division name
Faculty of Frontier Engineering, Institute of Science & Engineering
Zip code
920-1192
Address
Kakuma-machi, Kanazawa-shi, Ishikawa
TEL
076-234-4760
Homepage URL
yuichi@se.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
MTG co., ltd.,
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
IRB if the Kanazawa University
Address
13-1, Takaramachi, Kanazawa, Ishikawa
Tel
076-265-2048
hpsangak@adm.kanazawa-u.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
金沢大学(石川県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 04 | 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
60
Results
EMS intervention at 20 Hz was found to be most conducive to increasing cognitive function and blood BDNF levels.
Results date posted
| 2024 | Year | 02 | Month | 26 | Day |
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
| 2020 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None noted
Management information
Registered date
| 2020 | Year | 12 | Month | 04 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048671
| 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 |
