UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062602 |
|---|---|
| Receipt number | R000071662 |
| Scientific Title | Development and Evaluation of a Pressure Distribution Assessment System for Stable Transcranial Magnetic Stimulation |
| Date of disclosure of the study information | 2026/08/24 |
| Last modified on | 2026/08/18 15:01:15 |
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Basic information
Public title
Development and Evaluation of a Pressure Distribution Assessment System for Stable Transcranial Magnetic Stimulation
Acronym
Pressure Distribution System for TMS Coil Positioning
Scientific Title
Development and Evaluation of a Pressure Distribution Assessment System for Stable Transcranial Magnetic Stimulation
Scientific Title:Acronym
Pressure Distribution System for TMS Coil Positioning
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a system that quantitatively evaluates, as a pressure distribution, whether the center of a transcranial magnetic stimulation (TMS) coil is in close contact with the scalp, using pressure sensors attached to the coil. The study evaluates whether real-time feedback of this pressure distribution stabilizes coil positioning and enables more stable recording of motor evoked potentials (MEPs).
Basic objectives2
Others
Basic objectives -Others
Development of a pressure-sensor-based system for quantifying TMS coil contact with the scalp, and exploratory evaluation of the effect of positional feedback on coil stability and the reproducibility of MEP recordings
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Study 1: Stability of the TMS coil pressure distribution and its center of pressure.
Study 2: Mean, standard deviation and coefficient of variation of MEP amplitude, and standard deviation of the TMS coil pressure distribution and center of pressure.
Study 3: Correlation between displacement of the coil center of pressure and coil tilt.
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Study 1: A TMS coil fitted with pressure sensors is held over the left primary motor cortex hotspot for 3 minutes, and variation in the pressure distribution and center of pressure is recorded. No magnetic stimulation is delivered; only coil positioning is performed. Sensor configurations of 3 (standard), 4 and 6 sensors are compared.
Study 2: Single-pulse TMS is delivered to the left primary motor cortex hotspot at 120% of the resting motor threshold, once every 5-7 seconds, in 3-5 blocks of 20 pulses (60-100 pulses in total). Blocks alternate between pressure-distribution feedback on or off, and MEPs are recorded from the right first dorsal interosseous muscle by surface electromyography.
Study 3: Using an optical neuronavigation system (Brainsight), markers are placed on the TMS coil and on the scalp, and the displacement of the center of pressure from the coil center and the coil tilt are measured in real time to evaluate their correlation.
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 consent.
2) Able to provide written informed consent of their own free will.
Key exclusion criteria
1) Ongoing treatment for, or a history of, neurological or psychiatric disease (e.g. a history of febrile seizures).
2) Pregnant or possibly pregnant women.
3) Cancer, chronic hepatitis or other internal disease with metabolic abnormality that may affect brain function.
4) Implanted electrical stimulation devices such as a pacemaker, or implanted metal.
5) Uncontrolled bleeding.
6) Any other reason judged by the principal investigator to make participation inappropriate.
Target sample size
27
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
Department of Pharmacy, Faculty of Pharmaceutical Sciences, 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
Department of Pharmacy, Faculty of Pharmaceutical Sciences, Fukuoka
Division name
Department of Pharmacy, Faculty of Pharmaceutical Sciences, 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
Department of Pharmacy, Faculty of Pharmaceutical Sciences, Fukuoka
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 | 01 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 06 | 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=R000071662
