UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057885 |
|---|---|
| Receipt number | R000066162 |
| Scientific Title | Modulatory Effects of Visual Stimuli on Cortical Activation During Action Observation and Motor Imagery |
| Date of disclosure of the study information | 2025/05/16 |
| Last modified on | 2026/05/17 15:57:24 |
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Basic information
Public title
How the Brain Works When Imagining Movements While Watching Videos, and How Practice Helps
Acronym
MI-VIS Study
Scientific Title
Modulatory Effects of Visual Stimuli on Cortical Activation During Action Observation and Motor Imagery
Scientific Title:Acronym
MI-VIS Study
Region
| Japan |
Condition
Condition
no
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Motor imagery (MI) is defined as the conscious mental rehearsal of movements involving internal motor representations similar to those engaged during actual execution. Meta-analyses using fMRI have shown that MI activates motor-related regions such as the primary motor cortex and premotor areas. Repeated use of MI, known as mental practice (MP), is widely applied in sports and rehabilitation, including for patients with motor paralysis. The effectiveness of MP depends on the vividness of MI, which can be enhanced through action observation (AO). In particular, first-person perspective videos of one's own hand have been shown to increase corticospinal excitability. In our previous study using near-infrared spectroscopy (NIRS), we found that viewing one's own hand during AO+MI significantly increased both cortical activity and MI vividness compared to other-hand or no-video conditions. Similar results have been observed in stroke patients. One possible mechanism for these effects is the sense of body ownership induced by self-related visual stimuli. Previous studies using the rubber hand illusion have shown that body ownership is linked to multisensory integration and activation of regions such as the right temporoparietal junction and posterior insula. However, the neural correlates of body ownership during AO, MI, or AO+MI tasks remain largely unexplored.
Basic objectives2
Others
Basic objectives -Others
This study aims to investigate the relationship between the vividness of motor imagery (MI) and brain activity during action observation (AO), motor imagery (MI), and combined action observation and motor imagery (AO+MI) tasks, using functional magnetic resonance imaging (fMRI) and paired-pulse transcranial magnetic stimulation (TMS) in right-handed healthy adults. Furthermore, the study examines how repeated practice of AO+MI tasks and actual motor execution influences cortical activity and task performance.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor evoked potentials (MEPs) in motor and motor-related areas elicited by transcranial magnetic stimulation (TMS)
Key secondary outcomes
(a) Duration and number of movements in actual motor performance
(b) Maximum voluntary muscle contraction (MVC) of upper limb muscles
(c) Scores on questionnaires assessing motor imagery ability, MI vividness, sense of body ownership, and sense of agency
(d) Brain activation volumes obtained from structural MRI, DTI, resting-state fMRI, and task-based fMRI
(e) Amplitude of H-reflex, M-wave, and F-wave
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants will be randomly assigned to one of two intervention groups: a mental practice (MP) group using videos of another person's hand, or an MP group using videos of their own hand. The intervention consists of daily practice sessions lasting 30 to 60 minutes, including mental practice and actual execution tasks involving chopstick and scissor use with the left hand. The intervention can be conducted at home. The intervention period will range from at least one week to a maximum of one month. After the intervention, brain activity will be evaluated using fMRI and TMS during six AO+MI task conditions.Video presentation during the intervention will be delivered via a tablet device. The intervention can be conducted at home, and participants will be asked to manage and report their daily practice using Google Forms. The observation period for each participant will last for six months from the date of study initiation, and follow-up will be conducted via email.
Interventions/Control_2
Participants will be assigned to a mental practice (MP) group using videos of their own hand. They will perform daily practice sessions lasting 30 to 60 minutes, which include mental practice and actual execution of tasks using the left hand (such as using chopsticks and scissors). The intervention can be conducted at home. The intervention period will range from at least one week to up to one month. After the intervention, brain activity will be evaluated using fMRI and TMS under six different AO+MI task conditions.
The intervention videos will be presented using a tablet device. The training can be performed at home, and participants will be asked to monitor and report their intervention progress using Google Forms. The observation period for each participant will be six months from the date of study enrollment, with follow-up conducted via email.
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
Eligibility Criteria
Participants will be considered eligible and enrolled in the study only if they meet all of the inclusion criteria and none of the exclusion criteria.
Inclusion Criteria
(a) Normal vision or corrected-to-normal vision with glasses or contact lenses.
(b) Aged between 18 and 65 years at the time of registration.
Key exclusion criteria
Exclusion Criteria
Participants will be excluded from the study if they meet any of the following criteria.
These criteria were established based on safety guidelines for functional MRI (fMRI).
(a) Individuals with neurological or orthopedic conditions that impair voluntary limb movement.
(b) Individuals with visual or hearing impairments, or intellectual disability (IQ below 70), that may interfere with task performance in the study.
(c) Presence of implanted medical devices such as a pacemaker, cochlear implant, or deep brain stimulation device.
(d) Presence of intracranial metallic objects, such as aneurysm clips.
(e) History of epilepsy.
(f) History of neurological disorders.
(g) Currently pregnant or possibly pregnant.
(h) Use of an insulin pump due to diabetes.
(i) Presence of vascular clips.
(j) Presence of internal metal implants such as plates or screws for fracture repair.
(k) Use of implanted medical devices such as artificial joints.
(l) Presence of tattoos, including cosmetic tattoos such as eyeliner or permanent makeup.
(m) Use of electrical nerve stimulation devices.
(n) Residual metallic objects in the head following brain surgery.
(o) Presence of retained metal fragments in the body due to injury or other reasons.
(p) Occupational history involving metal processing.
(q) Claustrophobia.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Irie |
Organization
Kyoto University
Division name
Clinical Cognitive Neuroscience, Advanced Occupational Therapy, Human Health Sciences
Zip code
606-8507
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3968
irie.keisuke.8n@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Irie |
Organization
Kyoto University
Division name
Clinical Cognitive Neuroscience, Advanced Occupational Therapy, Human Health Sciences
Zip code
606-8507
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3968
Homepage URL
irie.keisuke.8n@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research (KAKENHI)
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 the Graduate School of Medicine, Kyoto University, and the Faculty of Medicine, Kyoto University Hospital
Address
Ethics Support Office, Kyoto University Graduate School and Faculty of Medicine
Tel
075-753-4647
kenkyu-k@mail2.adm.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 16 | 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 | 06 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 16 | Day |
Last modified on
| 2026 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066162
