UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053323 |
|---|---|
| Receipt number | R000060865 |
| Scientific Title | The study of noninvasive language brain mapping using Magnetoencephalography |
| Date of disclosure of the study information | 2024/01/11 |
| Last modified on | 2025/01/11 17:21:24 |
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Basic information
Public title
The study of noninvasive language brain mapping using Magnetoencephalography
Acronym
The study of noninvasive language brain mapping using Magnetoencephalography
Scientific Title
The study of noninvasive language brain mapping using Magnetoencephalography
Scientific Title:Acronym
The study of noninvasive language brain mapping using Magnetoencephalography
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the possibility of the Steady-State Evoked Potentials (SS-EPs) using magnetoencephalography for language brain mapping.
Basic objectives2
Others
Basic objectives -Others
Investigating the accuracy of brain mapping using MEG
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Power spectral density of frequencies tagging the stimulation frequency during SS-EPs
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
To record the brain response by magnetoencephalography during the word stimuli.
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy adults
2. The native language is Japanese
4. The dominant hand is right
4. People who agree to participate in this study
Key exclusion criteria
1. History of neurological disorders
2. People who are contraindicated for MRI
3. People who are deemed to be ineligible by the researcher
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Shigeto |
Organization
Kyushu University
Division name
Division of Medical Technology, Department of Health Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
TEL
092-642-6732
shigetou@neuro.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Emi |
| Middle name | |
| Last name | Yamada |
Organization
Kyushu University
Division name
DepartmentofLinguistics, FacultyofHumanities
Zip code
819-0395
Address
744, Motooka, Nishi-ku, Fukuoka, Fukuoka
TEL
092-802-5100
Homepage URL
e.yamada@kyudai.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Institutional Review Board in Kyushu university
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.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
| 2024 | Year | 01 | Month | 11 | 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
Suspended
Date of protocol fixation
| 2023 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 01 | Month | 11 | Day |
Last modified on
| 2025 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060865
