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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026754
Receipt No. 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 2018/06/11

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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
Middle name
Last name Tetsuaki Kawase
Organization Tohoku University
Division name Graduate School of Biomedical Engineering
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7303
Email kawase@orl.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuaki Kawase
Organization Tohoku University
Division name Graduate School of Biomedical Engineering
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7303
Homepage URL
Email kawase@orl.med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
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
2018 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030716

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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