UMIN-CTR Clinical Trial

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
Email	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
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	Tohoku University Graduate School of Medicine Ethics Committee
Address	1-1 Seiryo-machi, Aoba-ku
Tel	022-717-8007
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030716