UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062601 |
|---|---|
| Receipt number | R000063984 |
| Scientific Title | Stimulation conditions for transcranial magnetic stimulation producing somatosensory extinction phenomena. |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/18 12:26:29 |
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Basic information
Public title
Stimulation conditions for transcranial magnetic stimulation producing somatosensory extinction phenomena.
Acronym
Transcranial magnetic stimulation to induce somatosensory extinction
Scientific Title
Stimulation conditions for transcranial magnetic stimulation producing somatosensory extinction phenomena.
Scientific Title:Acronym
Transcranial magnetic stimulation to induce somatosensory extinction
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of neural substitutes underlying sensory extinction caused by transcranial magnetic stimulation
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Somatoensory perception response modulated by differential TMS conditions (coil orientation, single pulse/dual pulse, contralateral/ipsilateral hemisphere)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
TMS coil orientation (PA vs AP)
Interventions/Control_2
Single pulse vs dual pulse
Interventions/Control_3
Contralateral vs ipsilateral hemisphere stimulation
Interventions/Control_4
Phase (90 vs 180 degree) synchronised by transcranial alternating current stimulation
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
Healthy adults who give informed consent by document after fully explained about the experiments
Key exclusion criteria
[1] No ongoing treatment or history of neurological or psychiatric disorders (e.g. excluding febrile convulsions).
[2] Pregnant or possibly pregnant women.
[3] With motor system disorders in both upper limbs (e.g. fractures, burns).
[4] Persons with metallic objects that interfere with transcranial magnetic stimulation, i.e. those with MRI-qualified pacemakers or magnetic substances in the body.
[5] Persons with metabolic disorders due to internal diseases such as cancer or chronic hepatitis, the effects of which on brain function cannot be ruled out.
Target sample size
15
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 Pharmaceutical Sciences at Fukuoka
Zip code
831-8501
Address
Enoki-zu 137-1, Okawa, Fukuoka
TEL
0944-89-2000
ogata_k@iuhw.ac.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 Pharmaceutical Sciences at Fukuoka
Zip code
831-8501
Address
Enoki-zu 137-1, Okawa, Fukuoka
TEL
0944-89-2000
Homepage URL
ogata_k@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Katsuya Ogata
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare
Address
Enoki-zu 137-1, Okawa, Fukuoka
Tel
0944-89-2000
q-rinri@iuhw.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
| 2026 | Year | 09 | Month | 01 | 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
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2028 | 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=R000063984
