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

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 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

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

Value
https://center6.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