UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035575 |
|---|---|
| Receipt number | R000040488 |
| Scientific Title | The contribution of contralateral or ipsilateral primary sensory cortex in visuomotor practice (VMP) dependent motor learning |
| Date of disclosure of the study information | 2019/01/17 |
| Last modified on | 2021/02/09 12:41:23 |
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Basic information
Public title
The contribution of contralateral or ipsilateral primary sensory cortex in visuomotor practice (VMP) dependent motor learning
Acronym
Motor learning and primary sensory cortex
Scientific Title
The contribution of contralateral or ipsilateral primary sensory cortex in visuomotor practice (VMP) dependent motor learning
Scientific Title:Acronym
Motor learning and primary sensory cortex
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the role of primary sensory cortex and primary motor cortex and their hierarchy in visuomotor skill acquisition, retention, and interlimb transfer.
Basic objectives2
Others
Basic objectives -Others
Brain neuroscience-neurophysiological research to elucidate brain information process in visuomotor learning.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Wrist target matching test for both hands before and after rTMS/sham cortical stimulation.
Key secondary outcomes
Visuomotor test (VMT) before, after and 2 weeks after rTMS+visuomotor practice
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
rTMS to right primary sensory cortex 1Hz 20 min
Interventions/Control_2
rTMS to left primary sensory cortex 1Hz 20 min
Interventions/Control_3
rTMS sham to right primary sensory cortex 1Hz 20 min
Interventions/Control_4
rTMS sham to left primary sensory cortex 1Hz 20 min
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
right handed
Key exclusion criteria
1) having neurological deficit/sensorimotor impairment
2)having epilepsy or convulsive disease
3)previously had brain surgery
4) left-handed (upper/lower limb
5) metal implant in head and neck region
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
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL
+81-22-717-8586
nagatomi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Mihoko |
| Middle name | |
| Last name | Ohnishi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL
+81-22-717-8586
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
Other
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-cho 2-1, Aoba-ku, Sendai, Japan
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
| 2019 | Year | 01 | Month | 17 | 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
| 2019 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 28 | 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
| 2019 | Year | 01 | Month | 17 | 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=R000040488
| 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 |
