UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neural mechanism of concurrent speech
Title of the study (Brief title)	Neural mechanism of concurrent speech
Region	Japan

Condition
Condition	healthy
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Revealing neural mechanism of concurrent speech using fMRI
Basic objectives2	Others
Basic objectives -Others	Revealing neural mechanism of perception of different speech simultaneously
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	hemodynamic response
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Functional magnetic resonance imaging, maximum 60 minutes per day, two days. Using 3 Tesla MRI.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male and Female
Key inclusion criteria	Voluntary participating healthy colleage students.
Key exclusion criteria	History of neurological disorders, metals inside body, extremely short-sighted, pregnant, auditory problems, left-handed are excluded.
Target sample size	40

Research contact person
Name of lead principal investigator	Ryuta Kawashima
Organization	Tohoku University
Division name	Institute of Development, Aging and Cancer, Applied Brain Science
Address	Seiryo-cho 4-1, Aoba-ku Sendai
TEL	022-707-7988
Email	ruta@tohoku.ac.jp

Public contact
Name of contact person	Teruo Hashimoto
Organization	Tohoku University
Division name	Institute of Development, Aging and Cancer, Division of Developmental Cognitive Neuroscience
Address	Seiryo-cho 4-1, Aoba-ku Sendai
TEL	022-707-8457
Homepage URL
Email	teruo.hashimoto.d6@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 06 Month 09 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 05 Month 31 Day
Anticipated trial start date	2016 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 07 Day
Last modified on	2016 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026099