UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Brain activation in language learning depends on the grammatical similarity
Title of the study (Brief title)	Artificial grammar learning
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate brain activation change during second language learning using fMRI
Basic objectives2	Others
Basic objectives -Others	To clarify the grammatical similarity between native and second languages during language learning
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Task performance and functional brain image.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Learning similar grammar to Japanese
Interventions/Control_2	Learning dissimilar grammar from Japanese
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	18 years-old <=
Age-upper limit	28 years-old >=
Gender	Male and Female
Key inclusion criteria	1. University students 2. Native speaker of Japanese 3. Right handed 4. no history of neurological illness
Key exclusion criteria	1. Have a medical history of a mental disorder 2. Have metal contained within your body 3. frequent drug user
Target sample size	60

Research contact person
Name of lead principal investigator	Ryuta Kawashima
Organization	Institute of Development, Aging and Cancer, Tohoku University
Division name	Department of Functional Brain Imaging
Address	4-1 Seiryo-cho, Aoba-ku, Sendai, Japan
TEL	022-717-7988
Email	ryuta.kawashima.a6@tohoku.ac.jp

Public contact
Name of contact person	JEONG HYEONJEONG
Organization	Institute of Development, Aging and Cancer, Tohoku University
Division name	Department of Functional Brain Imaging
Address	4-1 Seiryo-cho, Aoba-ku, Sendai, Japan
TEL	022-717-7988
Homepage URL
Email	hyeonjeong.jeong.b8@tohoku.ac.jp

Sponsor
Institute	Institute of Development, Aging and Cancer, Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization
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	2015 Year 05 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 02 Month 01 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	2015 Year 05 Month 08 Day
Last modified on	2018 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020238