UMIN-CTR Clinical Trial

Basic information
Public title	Comparison between activation of contralateral and ipsilateral corticofugal pathway in deltoid muscle in human.
Acronym	Comparison between activation of contralateral and ipsilateral corticofugal pathway.
Scientific Title	Comparison between activation of contralateral and ipsilateral corticofugal pathway in deltoid muscle in human.
Scientific Title:Acronym	Comparison between activation of contralateral and ipsilateral corticofugal pathway.
Region	Japan

Condition
Condition	healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1) The revelation of reliability about method of transcranial magnetic stimulation in deltoid muscle. 2) The acquisition of reference data which are comparable to patients of central nerve system disease by measuring the activation of ipsilateral and corticospinal corticofugal pathways in human.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	active motor threshold
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Contralateral or ipsilateral primary motor area is stimulated by means of magnetic stimulator (Magstim 200, The Magstim Company Ltd, UK), and motor evoked potentials are measured from deltoid muscle. The measurements are performed during two separate testing sessions, separated by more than 48 hours. It takes around 1.5-2 hours at time to measure.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Volunteer older than age 20 years old who does not have the past of a nerve, the muscular disorder
Key exclusion criteria	(1)Metal is buried in the part near the stimulation part (2)The past of epilepsy (3)The past of the intracranial lesion (4)Internal use career of anticonvulsant (5)Sleep shortage (6)Alcohol dependence (7)The pregnancy (8)serious heart disease
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Meigen Liu
Organization	School of Medicine, Keio University
Division name	Department of Rehabilitation Medicine
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3833
Email	meigenliukeio@me.com

Public contact
1st name of contact person	1st name Middle name Last name Miho Hiramoto
Organization	School of Medicine, Keio University
Division name	Department of Rehabilitation Medicine
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3833
Homepage URL
Email	miho-hiramoto@keio.jp

Sponsor
Institute	School of Medicine, Keio University
Institute
Department

Funding Source
Organization	School of Medicine, Keio 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	2016 Year 09 Month 15 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 08 Month 15 Day
Date of IRB	2016 Year 08 Month 08 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2019 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 08 Month 17 Day
Last modified on	2019 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027248