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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035575
Receipt No. 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 2019/01/17

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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
Middle name
Last name Ryoichi Nagatomi
Organization Tohoku University
Division name Graduate School of Biomedical Engineering
Zip code
Address Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL +81-22-717-8586
Email nagatomi@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mihoko Ohnishi
Organization Tohoku University
Division name Graduate School of Biomedical Engineering
Zip code
Address Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL +81-22-717-8586
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 Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Anticipated trial start date
2019 Year 02 Month 01 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
2019 Year 01 Month 17 Day
Last modified on
2019 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040488

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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