UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062822 |
|---|---|
| Receipt number | R000071390 |
| Scientific Title | Elucidation of the Neural Circuit Mechanisms Underlying Fatigue Resistance During Muscle Fatigue |
| Date of disclosure of the study information | 2026/09/04 |
| Last modified on | 2026/09/04 13:54:30 |
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Basic information
Public title
Elucidation of the Neural Circuit Mechanisms Underlying Fatigue Resistance During Muscle Fatigue
Acronym
Elucidation of the Neural Circuit Mechanisms Underlying Fatigue Resistance During Muscle Fatigue
Scientific Title
Elucidation of the Neural Circuit Mechanisms Underlying Fatigue Resistance During Muscle Fatigue
Scientific Title:Acronym
Elucidation of the Neural Circuit Mechanisms Underlying Fatigue Resistance During Muscle Fatigue
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the neural mechanisms that support fatigue resistance, enabling the continuation of physical activity despite peripheral and central fatigue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Repetitive transcranial magnetic stimulation to brain region
Interventions/Control_2
Sham rRepetitive transcranial magnetic stimulation to brain region
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who have received a sufficient explanation of the study and have provided written informed consent.
Individuals who do not meet any of the exclusion criteria for the MRI measurement experiment.
Individuals who are able to participate in the handgrip task, surface electromyography recording, maximum voluntary contraction measurement, transcutaneous electrical stimulation, and twitch assessment when necessary.
For participants enrolled in experiment 3, safety screening will be conducted prior to TMS administration using Pre-MRI Screening Questionnaire, together with an assessment of the participant's physical condition on the day of the experiment, to identify any contraindications or risk factors related to TMS. The questionnaire assesses medication use, history of surgery, presence of metallic implants or foreign bodies, history of metalworking, history of seizures or epilepsy, panic attacks, possibility of pregnancy, claustrophobia or fear of darkness, implanted medical devices such as pacemakers, cochlear implants, intravascular devices, or aneurysm clips, alcohol consumption, sleep deprivation, neurological or psychiatric disorders, and family history of seizures or epilepsy.
In addition, on the day of TMS administration, participants will be asked about the use of medications that may affect seizure threshold, recent alcohol consumption, sleep deprivation, severe fatigue, poor physical condition, headache, history of unexplained loss of consciousness, head injury, neurosurgical procedures, and febrile seizures. If any of these factors are present, or if there are safety concerns based on the participant's responses, the principal investigator or a physician will review the information and determine whether TMS can be safely administered. If safety concerns remain, the TMS session will be postponed or canceled.
Key exclusion criteria
-Individuals with contraindications to MRI, including claustrophobia, metallic implants or foreign bodies, cardiac pacemakers, cochlear implants, or other implants containing ferromagnetic materials.
-Individuals with a history of epilepsy or seizure disorders.
-Individuals with intracranial metal implants, cerebral aneurysm clips, deep brain stimulation devices, or other implanted medical devices.
-Individuals with severe neurological, muscular, orthopedic, cardiovascular, respiratory, or psychiatric disorders for whom participation in the study is considered inappropriate.
-Individuals with pain, injury, dermatological conditions, or sensory impairment affecting the forearm or fingers that would make it difficult to perform the handgrip task or undergo transcutaneous electrical stimulation.
-Individuals who are considered likely to experience severe pain, discomfort, or skin-related adverse reactions in response to electrical stimulation.
-Individuals who are pregnant or may be pregnant.
-Individuals whom the principal investigator or a co-investigator determines to be unsuitable for participation in this study for any other reason.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Nishimura |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Neural Prosthetics Project
Zip code
156-8506
Address
Kamikitazawa 2-1-6, Setagaya-ku, Tokyo, Japan
TEL
03-6834-2375
nppj@igakuken.or.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Sugawara |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Neural Prosthetics Project
Zip code
156-8506
Address
Kamikitazawa 2-1-6, Setagaya-ku, Tokyo, Japan
TEL
03-6379-8411
Homepage URL
nppj@igakuken.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Medical Science
Institute
Department
Personal name
Funding Source
Organization
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
Tokyo Metropolitan Institute of Medical Science
Address
Kamikitazawa 2-1-6, Setagaya-ku, Tokyo, Japan
Tel
03-5316-3107
hito-rinri@igakuken.or.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 | 09 | 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
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
| 2026 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2032 | Year | 07 | Month | 23 | 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 | 09 | Month | 04 | Day |
Last modified on
| 2026 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071390
