UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046524 |
|---|---|
| Receipt number | R000053083 |
| Scientific Title | Study on interlimb transfer and brain wave changes of motor skills by left- and right-handed |
| Date of disclosure of the study information | 2022/01/03 |
| Last modified on | 2022/03/22 17:18:00 |
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Basic information
Public title
Study on interlimb transfer and brain wave changes of motor skills by left- and right-handed
Acronym
Study on interlimb transfer and brain wave changes of motor skills by left- and right-handed
Scientific Title
Study on interlimb transfer and brain wave changes of motor skills by left- and right-handed
Scientific Title:Acronym
Study on interlimb transfer and brain wave changes of motor skills by left- and right-handed
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether handedness makes difference in the effect of cross-education of exercise skill and the flow of information exchanged in the left- and right- hemisphere motor cortex.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
EEG data:
1)Connectivity between brain regions: phase gradient index (PSI)
2)Relationship between performance and frequency allocation
Key secondary outcomes
Effect of unilateral upper limb motor skill training on healthy subjects with different dominant hands on skill changes of ipsilateral and contralateral muscles(speed, accuracy rate)
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
right-handed/ right hand training
Interventions/Control_2
right-handed/ left hand training
Interventions/Control_3
left-handed/ right hand training
Interventions/Control_4
left-handed/ left hand training
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 adults who gave full informed consent to the study and submitted a signed documen
Key exclusion criteria
1) medical history of brain damage or mental diseases
2) medical history of epilepsy or had a history of anti-epileptic medication
3) motor dysfunction of upper limbs.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8574
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL
022-717-8586
nagatomi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8574
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL
022-717-8586
Homepage URL
nagatomi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University, Graduate School of Biomedical Engineering
Institute
Department
Personal name
Funding Source
Organization
Tohoku University, Graduate School of Biomedical Engineering
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
Tohoku University
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
Tel
022-728-4105
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
| 2022 | Year | 01 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2022 | Year | 01 | Month | 03 | Day |
Last modified on
| 2022 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053083
