UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062604 |
|---|---|
| Receipt number | R000071663 |
| Scientific Title | Optical evaluation using Leap Motion 2 of motor responses to transcranial magnetic stimulation of the primary motor cortex: comparison with motor evoked potentials |
| Date of disclosure of the study information | 2026/08/24 |
| Last modified on | 2026/08/18 15:49:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Optical evaluation of TMS-induced finger movements using Leap Motion 2
Acronym
Optical evaluation of TMS-induced finger movements using Leap Motion 2
Scientific Title
Optical evaluation using Leap Motion 2 of motor responses to transcranial magnetic stimulation of the primary motor cortex: comparison with motor evoked potentials
Scientific Title:Acronym
Optical evaluation of TMS-induced finger movements using Leap Motion 2
Region
| Japan |
Condition
Condition
Not applicable (basic research in healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of a novel optical motion-capture method (Leap Motion 2) for measurement (method/device evaluation)
Basic objectives2
Others
Basic objectives -Others
Comparison between an optical measurement method (Leap Motion) and surface EMG-based motor evoked potential (MEP) recording for TMS-induced finger movements
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Three-dimensional displacement of each finger (measured by Leap Motion), flexion/extension and abduction/adduction angles of each finger, motor evoked potential (MEP) amplitude
Key secondary outcomes
Correlation of coordinate changes between fingers, correlation of angular changes between fingers, correlation between MEP and finger movement, delay between MEP and finger movement onset (electromechanical delay)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
(Studies 1-5: single-arm, non-randomized, self-controlled, open-label. Each targets n=20; overlap across sub-studies permitted [total TBD, see "4. Eligibility"]. Each = one 1.5-2h session.)
Study1(n=20): Optical recording of TMS(M1)-induced finger movement via Leap Motion 2, with simultaneous surface EMG MEP(FDI). Single-pulse TMS 120%RMT, 30 pulses q5-7s. Evaluates MEP-movement delay (electromechanical delay) and MEP amplitude-index finger movement correlation.
Study2(n=20): Simultaneous Leap Motion kinematics and multichannel MEP (3-5ch: APB,FDI,ADM,FDS,EDC) at 120%RMT, 30 pulses. Evaluates inter-finger movement-MEP relations to determine optimal muscle placement.
Study3(n=20): Using Study2 setup, compares TMS intensities 100/120/140%RMT (30 pulses each, 90 total).
Study4(n=20): Using Study2 setup, (4-1) coil orientation PA vs AP (30 each, 60 total); (4-2) rest vs mild contraction 10-20%MVC (30 each, 60 total).
Study5(n=20): Electrical stim (3x sensory threshold) to index/little finger, M1 TMS 23ms later (SAI). TMS-only/index-paired/little-paired, 30 each, 90 total.
Interventions/Control_2
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[1] Healthy adult men and women aged 18 to 64 years at the time of obtaining consent
[2] Able to provide voluntary written informed consent
Key exclusion criteria
[1] Individuals receiving ongoing treatment for, or with a history of, neurological or psychiatric disease (excluding febrile seizures)
[2] Individuals with relative contraindications to TMS (e.g., intracranial metal foreign body, implanted electronic device, history of epilepsy, pregnant or possibly pregnant women)
[3] Individuals with musculoskeletal disease of both upper limbs (e.g., fracture, burn)
[4] Individuals with apparent motor or sensory impairment of the fingers
[5] Individuals with metabolic abnormalities due to internal medical conditions (e.g., cancer, chronic hepatitis) for whom an effect on cognitive/neurological function cannot be ruled out
[6] Other individuals judged by the principal investigator to be inappropriate for participation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Ogata |
Organization
International University of Health and Welfare
Division name
School of Pharmacy at Fukuoka
Zip code
831-8501
Address
Enokizu 137-1, Okawa, Fukuoka
TEL
0944-89-2000
ogata_k@ihwg.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Ogata |
Organization
International University of Health and Welfare
Division name
School of Pharmacy at Fukuoka
Zip code
831-8501
Address
Enokizu 137-1, Okawa, Fukuoka
TEL
0944-89-2000
Homepage URL
ogata_k@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
International University of Health and Welfare
Address
Enokizu 137-1, Okawa, Fukuoka
Tel
0944-89-2000
q-rinri@ihwg.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 | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2029 | 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 | 08 | Month | 18 | Day |
Last modified on
| 2026 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071663
