UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040959 |
|---|---|
| Receipt number | R000046776 |
| Scientific Title | Cerebral lateralization of ankle joint position sense in healthy left- and right-side dominant adults studied by functional magnetic resonance imaging |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2021/02/09 12:36:36 |
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Basic information
Public title
Cerebral lateralization of ankle joint position sense in healthy left- and right-side dominant adults studied by functional magnetic resonance imaging
Acronym
MRIJPS
Scientific Title
Cerebral lateralization of ankle joint position sense in healthy left- and right-side dominant adults studied by functional magnetic resonance imaging
Scientific Title:Acronym
MRIJPS
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Medicine in general | Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to comprehensively study the neural and behavioral correlates during ankle joint position sense (JPS) tasks in strongly right- or left-side dominant subjects to better understand how the brain processes the lower limbs position sense information.
Basic objectives2
Others
Basic objectives -Others
First, we will examine the laterality of the foot proprioceptive representation in the left-handed participants using two tasks, namely ipsilateral (i.e., memory-based) and contralateral (i.e., interhemispheric transfer) matching tasks to address controversy on their decreased laterality. Second, the degree of proprioceptive laterality in left-handed is going to be compared with that of laterality in other domains, namely the language and face processing to explore the potential common neural foundation of functional laterality across different cognitive domains. Finally, we will explore if such neural laterality in these domains is associated with the individual difference in the high-level social cognitive domain, specifically, the self-transcendence personality trait.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We will adopt a conventional two-level approach for a block-design fMRI data using SPM12. A voxel-by-voxel multiple regression analysis will be conducted for the first-level within-subject (fixed effects) model. We will construct for each subject a model of expected signal changes involving the four conditions; 2 measurement conditions(ipsilateral/contralateral) by 2 foot-laterality conditions(right/left).
Key secondary outcomes
Any deviation from the target position, discounting direction, was defined as the absolute position error:
1) E absolute = ABS(Xparticipant - Xtarget)
For constant error, the difference between reproduced and actual target angle was used, considering the direction of the error:
2) E constant = ( Xparticipant - Xtarget )
3) E variable: The variable error was calculated as the overall standard deviation (SD) of constant error from 14 trials, irrespective of the target range:
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Unilateral and bilateral active motor tasks:
Interventions/Control_2
Ipsilateral matching task:
Interventions/Control_3
Contralateral matching task:
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
healthy participants
more than 20 years old
left- and right-side dominant
Key exclusion criteria
history of neurological or orthopaedic disorders
other diseases
injury
claustrophobia
anything against performing MRI
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Division of Biomedical Engineering for Health & Welfare
Zip code
980-8575
Address
2-1, Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
8122-717-8588
nagatomi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Division of Biomedical Engineering for Health & Welfare
Zip code
980-8575
Address
2-1, Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
8122-717-8588
Homepage URL
nagatomi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
Seiryo-machi 2-1, Aoba-ku, Sendai
Tel
022-717-8007
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
| 2020 | Year | 08 | Month | 01 | 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
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 06 | Month | 30 | Day |
Last modified on
| 2021 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046776
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