UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058833 |
|---|---|
| Receipt number | R000067272 |
| Scientific Title | Cerebellar contribution on control of muscle activity - transcranial static magnetic stimulation study- |
| Date of disclosure of the study information | 2025/08/19 |
| Last modified on | 2025/08/19 11:37:43 |
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Basic information
Public title
Cerebellar contribution on control of muscle activity - transcranial static magnetic stimulation study-
Acronym
Cerebellar contribution on control of muscle activity - transcranial static magnetic stimulation study-
Scientific Title
Cerebellar contribution on control of muscle activity - transcranial static magnetic stimulation study-
Scientific Title:Acronym
Cerebellar contribution on control of muscle activity - transcranial static magnetic stimulation study-
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether transcranial static magnetic field stimulation (tSMS) over the right cerebellum modulates voluntary muscle activity during maximum voluntary contraction and neurophysiological indices (resting motor threshold, cerebellar brain inhibition) in healthy adults.
Basic objectives2
Others
Basic objectives -Others
Exploration of basic neurophysiological mechanisms
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in EMG activity of the right first dorsal interosseous muscle during maximum voluntary contraction (log-transformed post/pre ratio) [assessed immediately after stimulation].
Key secondary outcomes
Change in resting motor threshold (rMT) [assessed pre- and post-stimulation]
Change in cerebellar brain inhibition (CBI) [assessed pre- and post-stimulation]
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Triple-magnet tSMS over the right cerebellar hemisphere for 10minutes.
Interventions/Control_2
Sham stimulation using a visually identical non-magnetic device applied to the same site for 10 minutes.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18~59
No history of neurological or psychiatric disorders
Provided written informed consent
Key exclusion criteria
History of head trauma, seizures/epilepsy, or severe vertigo
Contraindications to magnetic stimulation (pacemaker, cochlear implant, implanted metals, neurostimulators, etc.)
Pregnancy or possible pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akiyoshi |
| Middle name | |
| Last name | Matsugi |
Organization
Shijonawate Gakuen University
Division name
Faculty of Rehabilitation
Zip code
574-0011
Address
5-11-10 Hojo, Daito, Osaka
TEL
072-863-5043
a-matsugi@reha.shijonawate-gakuen.ac.jp
Public contact
Name of contact person
| 1st name | Akiyoshi |
| Middle name | |
| Last name | Matsugi |
Organization
Shijonawate Gakuen University
Division name
Faculty of Rehabilitation
Zip code
574-0011
Address
5-11-10 Hojo, Daito, Osaka
TEL
072-863-5043
Homepage URL
a-matsugi@reha.shijonawate-gakuen.ac.jp
Sponsor or person
Institute
Shijonawate Gakuen University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
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 Committee of Shijonawate Gakuen University
Address
5-11-10 Hojo, Daito, Osaka
Tel
072-863-5043
a-matsugi@reha.shijonawate-gakuen.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 | 08 | Month | 19 | 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
44
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
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 01 | 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 | 08 | Month | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067272
