UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027491 |
|---|---|
| Receipt number | R000031490 |
| Scientific Title | Investigation of effects of pseudoexperience on the understanding of impossible actions: a basic study in healthy volunteers |
| Date of disclosure of the study information | 2017/05/25 |
| Last modified on | 2017/05/25 15:33:15 |
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Basic information
Public title
Investigation of effects of pseudoexperience on the understanding of impossible actions: a basic study in healthy volunteers
Acronym
Effects of pseudoexperience on the understanding of impossible actions
Scientific Title
Investigation of effects of pseudoexperience on the understanding of impossible actions: a basic study in healthy volunteers
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masato Taira |
Organization
Tokyo Medical and Dental University
Division name
Cognitive Neurobiology
Zip code
Address
1-5-45 MDtower7F, Yushima, Bunkyo-ku, Tokyo
TEL
0338055445
masato.cnb@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rui Watanabe |
Organization
Tokyo Medical and Dental University
Division name
Cognitive Neurobiology
Zip code
Address
1-5-45 MDtower7F, Yushima, Bunkyo-ku, Tokyo
TEL
0338055445
Homepage URL
rwtnb.cnb@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 05 | Month | 25 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031490
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
