UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062672 |
|---|---|
| Receipt number | R000071708 |
| Scientific Title | ffects of motor imagery combined with action observation and electrical stimulation on corticospinal excitability and imagery vividness |
| Date of disclosure of the study information | 2026/08/25 |
| Last modified on | 2026/08/24 20:20:28 |
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Basic information
Public title
Effects of motor imagery combined with action observation and electrical stimulation on corticospinal excitability and imagery vividness
Acronym
MAN-TMS study
Scientific Title
ffects of motor imagery combined with action observation and electrical stimulation on corticospinal excitability and imagery vividness
Scientific Title:Acronym
MAN-TMS study
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of combining action observation (AO) and neuromuscular electrical stimulation (NMES) with motor imagery (MI) of wrist flexion on corticospinal excitability, assessed using motor-evoked potentials (MEPs) elicited by transcranial magnetic stimulation (TMS), and subjective vividness of MI in healthy adults. By identifying intervention conditions that more effectively facilitate MI-related corticospinal excitability, this study may contribute to the optimization of MI-based interventions for individuals with stroke or musculoskeletal disorders and to the further development of neurorehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor evoked potentials obtained by transcranial magnetic stimulation
Vividness of motor imagery assessed using a visual analog scale (VAS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
neuromuscular electrical stimulation
Interventions/Control_2
action observation + motor imagery
Interventions/Control_3
neuromuscular electrical stimulation + motor imagery
Interventions/Control_4
action observation + neuromuscular electrical stimulation + motor imagery
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Heart disease, Head trauma, History of neurosurgery, History of spinal surgery, Central nervous system disorders, History of convulsions or epilepsy, History of fainting, Family history of epilepsy, Conditions aggravated by stress (e.g., asthma), Post-cardiac pacemaker implantation, Presence of implanted metal in the body, Respiratory or circulatory disorders, Neuropsychiatric disorders, Pregnancy, Hypertension, Hearing abnormalities or tinnitus, Sleep deprivation, Use of medications that lower the seizure threshold
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Hasegawa |
Organization
Nagasaki University
Division name
Graduate School of Biomedical Sciences, Health Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki City
TEL
095-819-7994
takashi_net184@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Hasegawa |
Organization
Nagasaki University
Division name
Graduate School of Biomedical Sciences, Health Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki City
TEL
095-819-7994
Homepage URL
takashi_net184@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki 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
Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki City
Tel
095-819-7994
takashi_net184@yahoo.co.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 | 08 | Month | 25 | 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 | 08 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 12 | 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 | 08 | Month | 24 | Day |
Last modified on
| 2026 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071708
