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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040959
Receipt No. 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 2020/06/30

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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
Email 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
Email nagatomi@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Email 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
Anticipated trial start date
2020 Year 08 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
2020 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046776

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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