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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026392
Receipt No. 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 2019/03/05

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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
Email 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
Email ryut88@med.kyushu-u.ac.jp

Sponsor
Institute Graduate School of Medical Science, Kyushu University
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 13 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
2017 Year 03 Month 03 Day
Last modified on
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030320

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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