UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of effects of pseudoexperience on the understanding of impossible actions: a basic study in healthy volunteers
Title of the study (Brief title)	Effects of pseudoexperience on the understanding of impossible actions
Region	Japan

Condition
Condition	healthy adult volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of pseudoexperience of hemiplegic movements(i.e., touching and handling the hemiplegic hand) on the understanding of the feeling of hemiplegic movements and brain activity in regions involved in action recognition by using functional MRI.
Basic objectives2	Others
Basic objectives -Others	Investigation of the effects of a specific psychological task on brain activity
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Brain activity during observing the hemiplegic movements
Key secondary outcomes	Subjective assessments for hemiplegic movements with the questionnaires

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Group1: touching and handling the hemiplegic hand (15min) The number of intervention is once, thus the total intervention duration is 15min.
Interventions/Control_2	Group2: observation of the movie of hemiplegic hand movements (15min) The number of intervention is once, thus the total intervention duration is 15min.
Interventions/Control_3	Group3: no intervention The intervention duration is 0min.
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	40 years-old >
Gender	Male and Female
Key inclusion criteria	All the participants are free of any neurological or psychiatric disorder. Additionally, they have no interaction experience with individuals with hemiplegia.
Key exclusion criteria	Participants who do not correspond to the above criteria.
Target sample size	45

Research contact person
Name of lead principal investigator	Masato Taira
Organization	Tokyo Medical and Dental University
Division name	Cognitive Neurobiology
Address	1-5-45 MDtower7F, Yushima, Bunkyo-ku, Tokyo
TEL	0338055445
Email	masato.cnb@tmd.ac.jp

Public contact
Name of contact person	Rui Watanabe
Organization	Tokyo Medical and Dental University
Division name	Cognitive Neurobiology
Address	1-5-45 MDtower7F, Yushima, Bunkyo-ku, Tokyo
TEL	0338055445
Homepage URL
Email	rwtnb.cnb@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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	2017 Year 05 Month 25 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 25 Day
Anticipated trial start date	2017 Year 07 Month 25 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	2017 Year 05 Month 25 Day
Last modified on	2017 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031490