UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061215 |
|---|---|
| Receipt number | R000070028 |
| Scientific Title | Acute and Chronic Effects of Electrical Muscle Stimulation on Cognitive Function and Associated Factors |
| Date of disclosure of the study information | 2026/04/10 |
| Last modified on | 2026/04/09 17:33:34 |
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Basic information
Public title
Effects of Electrical Muscle Stimulation on Cognitive Function
Acronym
Electrical Muscle Stimulation and Cognitive Function
Scientific Title
Acute and Chronic Effects of Electrical Muscle Stimulation on Cognitive Function and Associated Factors
Scientific Title:Acronym
Acute and Chronic Effects of Electrical Muscle Stimulation on Cognitive Function
Region
| Japan |
Condition
Condition
Healthy young individuals
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Electrical muscle stimulation has been reported to acutely enhance cognitive function; however, the underlying physiological mechanisms remain unclear. Therefore, this study aims to evaluate changes in neural activity during cognitive task performance and brain-related blood biomarkers following a single session of electrical muscle stimulation, as well as to examine its long-term effects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Neural activity
Cognitive function
BDNF, cathepsin B, lactate, and glucose
Mood state
cardiac output, blood pressure, and heart rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Electrical stimulation of skeletal muscle (3 times per week for 8 weeks)
Interventions/Control_2
rest
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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals without regular exercise habits
Key exclusion criteria
Individuals with visual or color vision impairments
Individuals with chronic diseases
Individuals with a history of smoking
Individuals who have undergone blood sampling within 12 weeks prior to study initiation
Individuals deemed unsuitable for electrical stimulation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hashimoto |
| Middle name | |
| Last name | Takeshi |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1, Noji-Higashi, Kusatsu, Shiga
TEL
077-599-4134
thashimo@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Dora |
| Middle name | |
| Last name | Kento |
Organization
Ritsumeikan University
Division name
Research Organization of Science and Technology
Zip code
525-8577
Address
1-1-1, Noji-Higashi, Kusatsu, Shiga
TEL
077-599-4134
Homepage URL
k-dora@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
Japanese Ministry of Education, Culture, Sports, Science, and Technology
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
Ethics Review Committee for Medical and Health Research Involving Human Subjects (natural Sciences), Ritsumeikan University
Address
1-1-1, Noji-Higashi, Kusatsu, Shiga
Tel
077-599-4175
b-rinri@st.ritsumei.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
| 2026 | Year | 04 | Month | 10 | 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
| 2025 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 04 | Month | 09 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070028
