UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026392 |
|---|---|
| Receipt number | R000030320 |
| Scientific Title | Neural mechanisms of cortical plasticity induced by incomplete ischemic nerve block of forearm: Investigating neural basis using evoked potentials |
| Date of disclosure of the study information | 2017/03/06 |
| Last modified on | 2019/09/10 23:46:01 |
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Basic information
Public title
Neural mechanisms of cortical plasticity induced by incomplete ischemic nerve block of forearm: Investigating neural basis using evoked potentials
Acronym
Neural mechanisms of cortical plasticity induced by incomplete ischemic nerve block of forearm
Scientific Title
Neural mechanisms of cortical plasticity induced by incomplete ischemic nerve block of forearm: Investigating neural basis using evoked potentials
Scientific Title:Acronym
Neural mechanisms of cortical plasticity induced by incomplete ischemic nerve block of forearm
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We propose a new method called incomplete ischemic nerve block (iINB) that induces the short-term plasticity of Sensory-Motor cortex. We will explore the underlying mechanisms of neural plasticity by iINB with using evoked potentials.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amplitudes of MEPs and SEPs
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Incomplete ischemic nerve block in the forearm using tourniquet
Interventions/Control_2
Interventions/Control_3
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1:All subjects give their written informed consent.
2:Right handed
Key exclusion criteria
1:The person has history of neurological problems.
2:History of the thrombosis
3:Bleeding tendacy
4:Internal metal such as Cardiac pacemakers and Cochlear implant
5:Pregnancy
6:The person who thinks that study doctor attending is inadequate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shozo Tobimatsu |
Organization
Institute of Medical Sciences, Graduate School of Kyushu University
Division name
Department of Clinical Neurophysiology
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582Japan
TEL
092-642-5543
tobi@neurophy.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryutaro Hayashi |
Organization
Institute of Medical Sciences, Graduate School of Kyushu University
Division name
Department of Clinical Neurophysiology
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582Japan
TEL
092-642-5543
Homepage URL
ryut88@med.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Science, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 03 | Month | 06 | 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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 03 | Month | 03 | Day |
Last modified on
| 2019 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030320
| Research Plan | |
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| 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 |
