UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026754 |
|---|---|
| Receipt number | R000030716 |
| Scientific Title | Visualization of the auditory feedback mechanism during the vocalization tuned to the pitch of the presented sound (exploratory study using the magnetoencephalography) |
| Date of disclosure of the study information | 2017/03/29 |
| Last modified on | 2021/01/28 13:55:23 |
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Basic information
Public title
Visualization of the auditory feedback mechanism during the vocalization tuned to the pitch of the presented sound (exploratory study using the magnetoencephalography)
Acronym
Visualization of the auditory feedback mechanism
Scientific Title
Visualization of the auditory feedback mechanism during the vocalization tuned to the pitch of the presented sound (exploratory study using the magnetoencephalography)
Scientific Title:Acronym
Visualization of the auditory feedback mechanism
Region
| Japan |
Condition
Condition
subjects with normal hearing
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Visualization of cortical activity during the vocalization tuned to the pitch of the presented sound
Basic objectives2
Others
Basic objectives -Others
Elucidation of mechanism
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of cortical activity during the vocalization tuned to the pitch of the presented sound
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
magnetoencephalography
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) age: 20 years old or older than 20 years, and younger than 60 years old
2) performance status = 0
Key exclusion criteria
1) Subjects with past history of the peripheral or central neurologic disease
2) Past history of the ear disease
3) Subjects with past history of mental disease
4) Subjects using a pacemaker and/or an implantable defibrillator
5) Subjects with the metals in the body
6) Subjects with scotophobia and/or claustrophobia
7) Subjects with the possibility of the pregnancy
8) Subjects who wear clothing (e.g., heat technical centers) for the cold protection using the new material
9) Subjects whom researchers judged to be inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tetsuaki |
| Middle name | |
| Last name | Kawase |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7303
kawase@orl.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuaki |
| Middle name | |
| Last name | Kawase |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7303
Homepage URL
kawase@orl.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Education, Culture, Sports, Science and Technology-Japan
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
Tohoku University Graduate School of Medicine Ethics Committee
Address
1-1 Seiryo-machi, Aoba-ku
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2017 | Year | 03 | Month | 29 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/journal/brain-research
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
12
Results
The attention and/or motivation required to extract the information from the stimulus tones may have caused N100m latency shortening.
Results date posted
| 2021 | Year | 01 | Month | 28 | Day |
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
| 2017 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2017 | Year | 03 | Month | 29 | Day |
Last modified on
| 2021 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030716
